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Methods

PMC10589316

Subjects

epilepsy, somatic pain, psychiatric, MDD, NRS

WEST, DISORDERS, EPILEPSY

Eighty MDD patients with moderate somatic pain were recruited from the Mental Health Center and the Neurobiological Laboratory, Sichuan University, West China Hospital. They had not received any analgesics or anti-depressants for at least 2 weeks before enrollment. Patients were randomly assigned to the DT group (n = 40) and CT group (n = 40) according to a computer-generated list. An experienced psychiatrist blinded to the group assignment performed psychiatric examinations on all patients to diagnose MDD. Inclusion criteria were: aged 18–60 years, met DSM-V criteria for MDD, 24-item HAMD score > 20, NRS score ≥ 4. Patients with other Axis I and Axis II psychiatric disorders were excluded. Exclusion criteria also included treatment with electroconvulsive therapy (ECT) or rTMS in the last year, epilepsy, pregnancy and contraindications to magnetic exposure (e.g., cranial plates). All subjects were of the Han nationality, and were right-handed, with normal hearing and no severe or acute medical conditions, based on clinical evaluations and medical records.All participants provided written informed consent before the start of the study. All methods were performed according to the relevant guidelines and regulations, which were approved by the Human Research Ethics Committee of West China Hospital, Sichuan University. Sertraline was given at a daily dose of 50 mg for 1 week, followed by a daily dose of 100 mg for both the DT and CT groups.

PMC10589316

rTMS stimulation and evaluations

NRS

rTMS simulations were carried out using a Magstim Rapid2 stimulator (Magstim Company, Spring Gardens, UK) with a figure-of-eight coil (double wings of 70-mm diameter). Coil placement was 5 cm anterior to the left and right motor hotspots. The resting motor threshold (RMT) of the right abductor pollicis brevis muscle was used to determine the lowest strength of TMS needed to elicit at least five motor-evoked potentials ≥ 50μV over 10 trials. Patients in the CT group received 15 sessions of bilateral active rTMS (five times a week for 3 weeks). The total pulse was 1600 per session with 90% RMT. First, intermittent theta burst stimulation (iTBS) was applied to the left DLPFC for 800 pulses, then, 800 pulses were applied to the right DLPFC at 1 Hz.ERPs were measured with MEB-9200 electromyogram/evoked potential equipment (Neuropack, Nihon Koden, Japan). The recording electrode was placed at Cz in the 10/20 system and the reference electrode was placed as a parallel electrode at the bilateral mastoid. MMN was evoked via headphones in the auditory oddball paradigm. Standard stimuli (60 dB nHL, 1000 Hz tones, envelope line of rise-plateau-fall were 10–100-10 ms) and deviant stimuli (80 dB nHL, 2000 Hz tones, the same as the envelope line) were presented in a ratio of 80%:20% in a randomized sequence, with a stimulus ratio at 1 Hz. The signals were averaged 40 times. MMN was obtained using subtractive processing between signals induced by deviant and standard stimuli in the absence of active attention. Subjects were not instructed to give any response to the target, only to lie relaxed with their eyes closed. The P300 was recorded under the same odd-ball paradigm, 30 times overlaid, and the waves were digitally filtered with a bandpass of 0.1 − 100 Hz. Subjects were instructed to press a button in response to the target. Analysis time and sensitivity were 100 ms/div and 20 μV/div, respectively, for all data. For all subjects, ERPs were measured and HAMD and NRS scores were evaluated three times: at baseline, after 3 weeks, and after 6 weeks.

PMC10589316

Author contributions

Y.S. wrote the main manuscript text; F.L., K.Z. and Z.Z. provided the conception and modified this text. All authors reviewed the manuscript.

PMC10589316

Funding

This work was supported by Sichuan Province cadres health research subject 2016-107, the Sichuan Natural Science Foundation (2023NSFC01235), the National Natural Sciences Foundation of China (81300065).

PMC10589316

Data availability

The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.

PMC10589316

Competing interests

The authors declare no competing interests.

PMC10589316

References

PMC10589316

Key Points

PMC10401301

Question

HEART, CARDIAC ARREST

Does the use of a tablet application cognitive aid reduce deviations from American Heart Association (AHA) resuscitation guidelines and improve the management of pediatric cardiac arrest?

PMC10401301

Findings

In this randomized clinical trial including 300 participants in 100 teams, the use of an interactive tablet application led to fewer deviations from AHA guidelines and better team performance compared with use of the AHA pocket reference card or no cognitive aid.

PMC10401301

Meaning

CARDIAC ARREST

This randomized clinical trial found that the use of the cognitive aid tablet application improved adherence to resuscitation guidelines, thus demonstrating promise for improving patient outcomes, although further studies are necessary to confirm these findings and demonstrate its impact in clinical practice.This randomized clinical trial assesses the effectiveness of a cognitive aid tablet application in improving the management of simulated in-hospital pediatric cardiac arrest.

PMC10401301

Importance

cardiac arrest

CARDIAC ARREST

Deviations from international resuscitation guidelines during the management of pediatric cardiac arrest are frequent and affect clinical outcomes. An interactive tablet application (app), PediAppRREST, was developed to reduce guideline deviations during pediatric cardiac arrest.

PMC10401301

Objective

PediAppRREST

CARDIAC ARREST

To assess the effectiveness of PediAppRREST in improving the management of simulated in-hospital pediatric cardiac arrest.

PMC10401301

Design, Setting, and Participants

This multicenter 3-group simulation-based randomized clinical trial was conducted from September 2020 to December 2021 at 4 Italian university hospitals (Padua, Florence, Rome, Novara). Participants included residents in pediatrics, emergency medicine, and anesthesiology. Analyses were conducted as intention-to-treat. Data were analyzed from January to June 2022.

PMC10401301

Interventions

PediAppRREST

AIDS, CARDIAC ARREST

Teams were randomized to 1 of 3 study groups: an intervention group that used the PediAppRREST app; a control group that used a paper-based cognitive aid, the Pediatric Advanced Life Support (PALS) pocket card; and a control group that used no cognitive aids. All the teams managed the same standardized simulated scenario of nonshockable pediatric cardiac arrest.

PMC10401301

Main Outcomes and Measures

SECONDARY

The primary outcome was the number of deviations from guidelines, measured by a 15-item checklist based on guideline recommendations. The main secondary outcomes were quality of chest compressions, team clinical performance (measured by the Clinical Performance Tool), and perceived team leader’s workload. Study outcomes were assessed via video reviews of the scenarios.

PMC10401301

Results

Overall 100 teams of 300 participants (mean [SD] age, 29.0 [2.2] years; 195 [65%] female) were analyzed by intention-to-treat, including 32 teams randomized to the PediAppRREST group, 35 teams randomized to the PALS control group, and 33 teams randomized to the null control group. Participant characteristics (210 pediatric residents [70%]; 48 anesthesiology residents [16%]; 42 emergency medicine residents [14%]) were not statistically different among the study groups. The number of deviations from guidelines was significantly lower in the PediAppRREST group than in the control groups (mean difference vs PALS control, −3.0; 95% CI, −4.0 to −1.9;

PMC10401301

Conclusions and Relevance

CARDIAC ARREST

In this randomized clinical trial, the use of the PediAppRREST app resulted in fewer deviations from guidelines and a better team clinical performance during the management of pediatric cardiac arrest.

PMC10401301

Trial Registration

ClinicalTrials.gov Identifier:

PMC10401301

Introduction

cardiac arrest

HEART, SEQUELAE, CARDIAC ARREST

Pediatric cardiac arrest is a rare emergency associated with high mortality and important clinical sequelae.In 2019, we developed an interactive, multimodal, electronic cognitive aid in the form of a tablet application (app), named PediAppRREST, to provide decision support to the team leader through a clickable list of actions to be performed in a stepwise manner, closely following the American Heart Association (AHA) resuscitation guidelines. The app was developed and refined through an iterative prototyping approach on the basis of users’ needs and feedback

PMC10401301

Methods

This randomized clinical trial was deemed a negligible risk study by the human ethics committee of the University Hospital of Padua and granted approval via a fast-tracked review process. All participants provided written informed consent. The study was reported according to the extended Consolidated Standards of Reporting Trials (

PMC10401301

Design, Setting, and Participants

This was a multicenter, simulation-based, 3-group parallel randomized clinical trial. The study was carried out between September 2020 and December 2021 at 4 Italian University Hospitals (Padua, Florence, Rome, and Novara), with analysis performed between January and June 2022. Residents in pediatrics, emergency medicine, and anesthesiology were recruited after providing written informed consent. Adult and pediatric Basic and Advanced Life Support–certified residents, following the AHA

PMC10401301

Interventions

cardiac arrest, PediAppRREST

CARDIAC ARREST

Participants were stratified by hospital location and residency specialty. Among PALS-certified residents, 1 participant was randomly assigned to each team with the role of team leader. Among the remaining PALS- and non-PALS–certified residents, 2 participants were randomly assigned to each team to obtain teams of 3 members, with at least 1 PALS-certified resident for the team leader role. Teams were block randomized to 1 of 3 study groups in a 1:1:1 ratio using a computer-based sequence and sealed envelopes. All the teams conducted the same scenario of pediatric cardiac arrest using a different cognitive aid according to the randomization allocation: the PediAppRREST app (PediAppRREST intervention group); a paper-based cognitive aid, the AHA PALS pocket reference card (PALS control group); or no cognitive aid (null control group). The standard simulation was a 10-minute scenario of nonshockable in-hospital pediatric cardiac arrest

PMC10401301

Outcomes

Two independent and trained reviewers (G.T. and E.F.)

PMC10401301

Primary Outcome

CARDIAC ARREST

The main outcome of the study was the number of deviations from PALS guidelines during the management of pediatric cardiac arrest, as measured by a 15-item checklist. For each item, a score of 1 point was assigned if a deviation (ie, delay, error, or omission) occurred, while zero was assigned if the action was correctly and timely performed. Scores ranged from 0 to 15, with lower the scores indicating fewer deviations from guidelines.

PMC10401301

Error Score Items for Nonshockable Pediatric Cardiac Arrest

pulseless, Shock

BLOOD, SHOCK, CARDIAC ARREST

CPR started within 30 s from recognition of pulseless state.CPR board or rigid surface positioned underneath the manikin within 60 s from recognition of pulseless state.Compression and ventilation ratio of 15:2.Help called (hospital emergency response system activated) within 60 s from recognition of pulseless state.Compressors switched more than once during CPR.EKG monitoring started within 60 s from recognition of pulseless state.IV or IO access called within 60 s from recognition of pulseless state.First epinephrine called within 30 s from recognition of pulseless state.First epinephrine administered at the correct dose and dilution and by the correct route (IV or IO), followed by a normal saline flush, while compressions are being performed, within 180 s (3 min) from recognition of pulseless state.Second epinephrine called between 3 and 5 min from the first administration of epinephrine.Second epinephrine administered at the correct dose and dilutiona and by the correct route, followed by a normal saline flush, while compressions are being performed, within 5 min from the first epinephrine.Blood gas called during cardiac arrest.Reversible causes treated.Shock not administered.Medications other than epinephrine (eg, amiodarone, lidocaine, atropine) not administered. Abbreviations: CPR, cardiopulmonary resuscitation; EKG, electrocardiogram; IO, intraosseous; IV, intravenous. Correct dose of epinephrine is defined as 0.01 mg/kg (or a deviation from the correct weight dose of <10%); correct dilution of epinephrine is defined as 1:10.000 (0.1 mg/mL). Administration of medications to treat identified reversible causes is not considered in this item.

PMC10401301

Secondary Outcomes

SECONDARY

We assessed 6 secondary outcomes. Performance and time (in seconds) to accomplish critical resuscitation interventions were measured.

PMC10401301

Statistical Analysis

Sample size was calculated considering the results obtained during our previous observationalThe results were summarized with counts and percentages for categorical variables and mean and SD for normally distributed quantitative variables. For variables with asymmetric distribution, we also reported the median and IQR. The data were analyzed with generalized linear models considering the analysis of variance for quantitative variables, binomial distribution for binary data, generalized logit for multinomial nonordinal data, and cumulative logit for multinomial ordinal data (eAppendix 2 in

PMC10401301

Results

We recruited 324 residents (108 teams). Eight teams did not participate in the trial due to sickness or withdrawal of consent, leaving 100 teams for the intention-to-treat analysis: 32 teams in the PediAppRREST group, 35 in the PALS group, and 33 in the null control group (

PMC10401301

Participant Demographic Characteristics and Previous Experience in Simulation and Resuscitation

ALS

Abbreviations: ALS, Advanced Life Support; ACLS, Advanced Cardiac Life Support; BLS, Basic Life Support; CPR, cardiopulmonary resuscitation; PALS, Pediatric Advanced Life Support; PBLS, Pediatric Basic Life Support.Data missing for 1 participant.Data missing for 2 participants.Data missing for 3 participants.Includes data for 32 team leaders in the PediAppRREST group, 35 team leaders in the PALS control group, and 33 team leaders in the null control group.

PMC10401301

Primary Outcome

The mean number of deviations from guideline recommendations, as measured by the error score, was significantly lower in the PediAppRREST group (mean [SD] 3.4 [2.0] points) compared with the 2 control groups (PALS: mean difference, −3.0; 95% CI, −4.0 to −1.94;

PMC10401301

Error Scores Overall and for Individual Items

Abbreviations: CPR, cardiopulmonary resuscitation; EKG, electrocardiogram; IO, intraosseous; IV, intravenous; NE, not estimable; PALS, Pediatric Advanced Life Support.Range, 0 to 15, with higher score indicating more errors.Expressed as mean difference (95% CI).Details of the correct performance of each item are provided in the Correct dose of epinephrine is defined as 0.01 mg/kg (or a deviation from the correct weight dose of <10%); correct dilution of epinephrine is defined as 0.1 mg/mL (1:10.000).The defibrillation is not indicated in the PALS algorithm for nonshockable rhythm.Administration of medications to treat identified reversible causes is not considered in this item.Analyses stratified by residency programs showed that in each residency group, the mean number of deviations from guidelines was lower in the PediAppRREST group than in the control groups (eTable 2 in

PMC10401301

Secondary Outcomes

PediAppRREST

Use of the PediAppRREST app, compared with both control groups, was associated with a significantly higher percentage of teams that positioned a CPR board or rigid surface underneath the patient (78.1% of PediAppRREST teams; 20.0% of PALS teams; The analysis of chest compression quality metrics did not show any statistically significant difference between the 3 study groups (

PMC10401301

Principle Secondary Outcomes Results

chest compression, PediAppRREST

Abbreviations: CC, chest compression; CPT, Clinical Performance Tool; PALS, Pediatric Advanced Life Support; R-TLX, raw NASA Task Load Index.Scores range from 0 to 13, with higher score indicating better performance. Includes data for 32 PediAppRREST teams, 35 PALS teams, and 33 null control teams.Scores range from 0 to 100, with higher score indicating higher perceived workload. Includes data for 32 PediAppRREST teams, 34 PALS teams, and 33 null control teams.The System Usability Scale scores showed a mean (SD) score of 74.8 (16.1) points. This result corresponds to a good rating (similar to a 5 on a 1-7 Likert scale).Team leaders’ workload was not statistically different among the 3 study groups. However, by analyzing the individual items of the score, the mean values for the mental demand item was significantly lower in the intervention group (mean [SD] score, 70.0 [20.9] points) than in the PALS (mean [SD] score, 81.3 [14.7];

PMC10401301

Discussion

ROSC, cardiac arrest, PediAppRREST

AIDS, CARDIAC ARREST

In this randomized clinical trial, we analyzed the effect of the use of the PediAppRREST tablet app on the management of a simulated case of pediatric cardiac arrest and found that its use was associated with fewer deviations from guidelines and a better team clinical performance compared with the use of the AHA reference pocket card and no cognitive aid. Given that deviations from recommendations are still frequent and are proven to affect clinical outcomes,The detected benefits of using the PediAppRREST app in our study could be related to its ability to provide multimodal interactive stepwise decision support to the team leader. In contrast, paper-based aids are static and usually display the entire algorithms in a 1-page format, requiring users to independently identify the correct steps in the algorithm and rapidly move through its decision nodes and treatment recommendations. This process can cause a mental overload in the users and in turn delay actions and increase management errors. Given the low complexity of the PediAppRREST cognitive aid, needing only a tablet as hardware support, it could potentially be easily implemented also in lower-resource settings. In addition, practice with the app through mental simulation could be facilitated and promoted by its download on personal smartphones.A 2022 meta-analysisTo our knowledge, only 1 other study has compared the effect of an electronic (smartphone app) cognitive aid with a paper-based aid and no cognitive aid, and it was conducted using adult case scenarios.With respect to the quality of CPR, we found that the use of the app did not impact chest compression quality metrics. However, this cognitive tool was not developed to support the compressors during CPR, thus an improvement of the quality of compressions was not expected. Different real-time feedback devices and a CPR coach have been proven to effectively improve the quality of compressions.Overall, our study found that the use of the PediAppRREST app globally improved the management of pediatric cardiac arrest, mostly by reducing omissions and errors that can impact clinical outcomes. The use of our app was associated with a higher proportion of ROSC than control groups. However, in our study, ROSC was achieved when predefined tasks were correctly completed during the management of the scenario. For this reason, while ROSC is an important outcome in real-life studies, it was not included as an outcome in our simulation-based trial.Most of the times to perform critical actions for resuscitation did not significantly differ between the study groups. This could be related to the limited prior exposure to the app by the team leaders, as the use of a new cognitive tool, by itself, takes time and cognitive effort. Professionals who frequently lead pediatric clinical emergencies and are not completely familiar with a cognitive aid could choose not to use it or could be delayed in their management by the tool; in contrast, cognitive aids could be more beneficial for less expert clinicians, for both ensuring all tasks are completed and for expediting management goals. Future studies should ascertain whether by improving users’ proficiency and efficiency in navigating PediAppRREST via increased practice could result in a reduction in time to perform critical actions compared with standard practice.While any cognitive support could potentially increase users’ workload, as it may distract from the management of the scenario by requiring extra attention and concentration to understand its use or follow its guidance, we found that the use of PediAppRREST was not associated with a higher perceived workload among users, and its usability was rated as good.

PMC10401301

Limitations

cardiac arrest

CARDIAC ARREST

This study has some limitations. The main limitation is that only residents were included as participants. We elected to include residents because they are frequently the frontline physicians managing the first minutes of a pediatric cardiac arrest in many institutions.

PMC10401301

Conclusions

CARDIAC ARREST

In this randomized clinical trial, teams using the PediAppRREST app had fewer deviations from international guidelines and a better clinical team performance during the management of simulated pediatric cardiac arrest. Further studies are necessary to understand the effectiveness of this aid in multidisciplinary team compositions reflecting the latest PALS recommendations. Before considering implementation in clinical practice, systematic simulation training with the app and further studies should be performed.

PMC10401301

Objectives

MIDDLE EAR

The aim of this work is to compare between different techniques of adenoidectomy: endoscopic microdebrider-assisted, coblation and conventional adenoidectomy and its effect on middle ear pressure.

PMC10764527

Background

inflammation, obstruction of the tubal, Eustachian tube dysfunction

INFLAMMATION, MIDDLE EAR, EUSTACHIAN TUBE DYSFUNCTION

Adenoidectomy, either alone or with tonsillectomy, is considered among the most performed procedures in pediatric otorhinolaryngology. This procedure usually related to the Eustachian tube function and middle ear status. Eustachian tube dysfunction is mainly caused by mechanical obstruction of the tubal orifice, insufficient swallowing and inflammation in the nasopharyngeal mucosa.

PMC10764527

Methods

adenoid hypertrophy, pain

ADENOID HYPERTROPHY, RECURRENCE, POSTOPERATIVE BLEEDING

This prospective randomized study was conducted on 90 patients with symptomatic adenoid hypertrophy confirmed by nasopharyngeal X-ray and endoscopic grading preoperatively. Patients were admitted at Otorhinolaryngology department of our institute during the period from January 2022 to January 2023. They were divided into three groups that were operated either by conventional (Group I), endoscopic microdebrider (Group II), or coblation technique (Group III). Each group was assessed through the audiometric parameters plus postoperative bleeding, and VAS results for pain score and postoperative endoscopic grading for adenoid recurrence.

PMC10764527

Results

Mean age in group A was 9.03 years and in group B was 8.99 years and was 8.99 years in group C with insignificant differences between three groups. There is significant improvement of tympanographic results comparing all groups of the patients at 6 months postoperatively. There is significant relation between the mean VAS comparing preoperative and postoperative results.

PMC10764527

Conclusion

There are better results in tympanographic data at conventional adenoidectomy versus other techniques. However, there are also better postoperative results after either coblation or endoscopic microdebrider adenoidectomy over the conventional technique.

PMC10764527

Keywords

Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB).

PMC10764527

Background

cor-pulmonale, inflammation, airway obstruction, adenoid hypertrophy, hemorrhage, obstruction of the tubal, Sleep-related breathing disorder, adenoid, maxillofacial anomalies, trauma

INFLAMMATION, AIRWAY OBSTRUCTION, SLEEP-RELATED BREATHING DISORDERS, EUSTACHIAN TUBE DYSFUNCTION, HEMORRHAGE, ADENOID HYPERTROPHY, MIDDLE EAR, PULMONARY HYPERTENSION, COMPLICATIONS

The adenoid also known as nasopharyngeal tonsils is a lymphatic tissue in the nasopharynx. It is situated in the midline on the roof and posterior wall of the nasopharynx. The adenoids are midline structures situated on the roof and posterior wall of the nasopharynx [Adenoid hypertrophy is one of the common causes of upper airway obstruction in children. Sleep-related breathing disorder due to adenoid is often seen in children aged 4–5 years, because at this age, the adenoid tissue and palatine tonsils have reached their largest size, untreated adenoid hypertrophy can lead to serious conditions such as maxillofacial anomalies, pulmonary hypertension and cor-pulmonale [Adenoidectomy, either alone or with tonsillectomy, is considered among the most performed procedures in pediatric otorhinolaryngology. Classical adenoidectomy is referred to as the curette adenoidectomy or conventional adenoidectomy, which utilizes a curette for adenoids removal [Afterwards, many alternative techniques have been suggested, including suction electrocautery ablation, laser adenoidectomy, and microdebrider-assisted adenoidectomy. Curettage technique that is widely used currently, remains quite popular. However, it has various complications, such as incomplete removal, trauma to underlying tissues and hemorrhage [Endoscopes began to be utilized in adenoidectomy operations to ensure full removal of the adenoid bulk, achieve better hemostatic control with enhanced visualization and prevent possible damage [Eustachian tube dysfunction is most commonly caused by mechanical obstruction of the tubal orifice, insufficient swallowing and inflammation in the nasopharyngeal mucosa [Our aim of this work is to compare between two different techniques of adenoidectomy: endoscopic microdebrider-assisted, coblation, and conventional adenoidectomy and its effect on middle ear pressure.

PMC10764527

Methods

bleeding, sleep disorder, Pain, choanal atresia, adenoid, Postoperative bleeding, ’ postoperative pain, palate, retrognathia or macrognathia, sleep disordered breathing, nasal obstruction, adenoid hypertrophy, maxillofacial anomalies, cleft lip, adenoid mass

OTITIS MEDIA WITH EFFUSION, HYPERTROPHIED, BLEEDING, POSTOPERATIVE BLEEDING, ALLERGIC RHINITIS, OTITIS MEDIA, PAD, BLIND, SLEEP DISORDERED BREATHING, COAGULATION DISORDER, ADENOID HYPERTROPHY, COMPLICATIONS

This prospective randomized study was conducted on 90 patients with symptomatic adenoid hypertrophy such confirmed by nasopharyngeal X-ray and endoscopic grading preoperatively. Patients were selected from general population including patients reporting to Otorhinolaryngology outpatient clinics of Al-Azhar University hospitals during the period from January 2022 to January 2023. It is approved by the ethical committee of the University with ethical No. (412/ENT/2022).Inclusion criteria were only children aged from 3 to 12 years old with symptomatic adenoid hypertrophy, children with sleep disordered breathing due to adenoid hypertrophy, tonsillectomy candidates that were assessed for the presence of asymptomatic adenoid hypertrophy, and these patients had no history of attack of otitis media in the last 6 months.Exclusion criteria were patients having significant nasal obstruction due to other causes such as: (allergic rhinitis, septal deviation, hypertrophied inferior turbinates or sinonasal polyps), patients with congenital nasal or maxillofacial anomalies such as: cleft lip and palate, choanal atresia, retrognathia or macrognathia, or patients with coagulation disorder, plus patients with past history of myringotomy, grommet tube, recurrent otitis media with effusion.Patients were subjected to the following: (1) detailed history taking and clinical examination. (2) radiological evaluation of the adenoid by X-ray lateral view on the nasopharynx. (3) endoscopic grading of adenoid size using flexible endoscopy (4) tympanometry for all patients.Preoperatively, before general anesthesia fiberoptic adenoid endoscopy was done with a 2.7 mm fiberoptic endoscope (Karl Storz, Germany). The aim of this examination is to detect the adenoid size grading as four grades as following: when only upper part of nasopharynx (free choanae) occupied by adenoid mass was classified as grade 1 (≤ 25%). Adenoid tissue occupied equal or less than 50% of nasopharynx with sufficient choanal opening and sufficient tubal visualization was classified as grade 2. If adenoid tissue occupies about 75% of the nasopharynx with partial involvement of the tube ostium and considerable obstruction of choanal openings was classified as grade 3. If adenoid tissue reaches the lower choanal border without allowing visualization of the tube ostium (> 75%) was classified as grade 4 [All patients underwent polysomnography before adenoidectomy to assess the presence of sleep disorder; then under general anesthesia all patients were operated either as a single procedure or along with other procedures like tonsillectomy. The patients were tabulated on computer and depending on double blind they were divided randomly into three groups: Group I of 30 patients had conventional adenoidectomy, Group II of 30 patients had endoscopic microdebrider-assisted adenoidectomy, and Group III of 30 patients had coblation adenoidectomy.Intraoperative endoscopic nasal examination after adenoidectomy was done to evaluate the presence of adenoid remanent in both groups and to control bleeding. Patients were recorded for operative time, operative and post-operative complications. Pediatric flexible nasopharyngoscopy was done for all patients 6 months postoperatively for re-assessment of the nose and nasopharynx. Informed written consent was obtained from all patients.Conventional adenoidectomy: patients were subjected to general anesthesia via an orotracheal tube. Then the child was placed in supine in the Rose position and Boyle Davis mouth gag was inserted as in tonsillectomy. Then St. Clair Thompson adenoid curette was used to perform a conventional adenoidectomy. A 70° endoscope was used for assessment of the presence of posterior pharyngeal wall injury or remnant of adenoid tissue. Ribbon gauze was placed in the nasopharynx for attaining hemostasis and was removed after 5 min.Endoscopic microdebrider-assisted adenoidectomy: patients were subjected to General Anesthesia via an orotracheal tube. Then the child was placed in supine in the Rose position and Boyle Davis mouth gag was inserted as in tonsillectomy. With the use of endoscope, the Microdebrider unit was set at 3000 rpm oscillating mode to remove the adenoid tissue from the choanal and tubaric regions transorally. Once all the adenoid tissue was removed, ribbon gauze was placed in the nasopharynx for attaining hemostasis and was removed after 5 min. Microdebrider with special adenoid blade, which is longer, has a window on convex side for use transorally to adapt to the roof of nasopharynx. A 70° sinoscope and angled microdebrider was passed transorally. The adenoidectomy was started high in the nasopharynx from upper limit of adenoid tissue, which often cannot be reached by conventional curette. Resection was continued from one side to another side fashion on an even level until the inferior edge of adenoid pad will be reached. The cutting and aspirating action of the shaver and simultaneous irrigation removes both adenoid tissue and the blood, thus providing a clear view. Postoperative care was given and patient was discharged the same day.Postoperative endoscopic assessment of any adenoid remnant after 6 months was done. Postoperative bleeding was evaluated postoperatively. The patients’ postoperative pain assessment were compared using VAS from 0 to 5 before operation, after 2 weeks, and 3 months after adenoidectomy as shown in Fig. Pain scale according to facial expression [Data were fed to the computer and analyzed using IBM SPSS software package version 20.0

PMC10764527

Discussion

deafness, bleeding, Adenoid enlargement, hearing loss, adenotonsillar hypertrophy, edema, Eustachian tube dysfunction, adenoid hyperplasia, OME, temporary dysfunction of Eustachian tube, pain, infection, fullness, hypoacusis, adenoid hypertrophy, adenoid tissue hypertrophy, Eustachian dysfunction

MIDDLE EAR EFFUSION, BLEEDING, HEARING LOSS, ADENOTONSILLAR HYPERTROPHY, BLOOD CLOTS, EDEMA, ADENOID HYPERPLASIA, EUSTACHIAN TUBE DYSFUNCTION, RECURRENT OTITIS MEDIA, HEARING IMPAIRMENT, INFECTION, ADENOID HYPERTROPHY, MIDDLE EAR

Adenoid enlargement is an important cause for Eustachian tube dysfunction and recurrent otitis media in pediatric population. In recent study by Somayaji et al., incidence of adenoid hypertrophy was more in 4–6-year age group, followed by 7–9-year age group. This observation was similar to the study by Fujioka et al., which showed that the size of adenoid varies among children, but the maximum size was between 4 and 8 years age, which then regress gradually by 15 years of age. There was no significant difference in the gender distribution of incidence of adenoid hypertrophy [Children with OME may remain asymptomatic. Some present with deafness or ear fullness. In the present study, 12 children (22.2%) had hearing impairment. This incidence varies depending on the study. In a similar study by Kindermann et al. to investigate whether the obstruction of the Eustachian tube orifice due to adenoid hyperplasia causes a change in the MEP showed that the incidence of hearing loss to be 16% (8 out of 50 children). Sarafoleanu et al., in their study, showed the implications of adenoid tissue hypertrophy in the genesis of Eustachian tube dysfunction observed the incidence of hypoacusis to be 77.8%. In another study by Khayat and Dabbagh to identify the incidence of OME in children with adenoid hypertrophy, 22 (50%) out of 44 children with OME had deafness which was detected by statements of parents and teachers. Enache et al. in his study on 119 children with OME observed that all children presented with a history of deafness [In a study by Somayaji et al., otoscopy findings showed varied appearance of TM. 24% (26 ears) showed air–fluid level and 17.6% (19 ears) had dull and retracted TM. Tympanogram results revealed pathological curves in 45 ears (25% Type B curve and 16.7% Type C curve). Sarafoleanu et al. in his study observed that 28.57% had retracted TM and 49.2% had middle ear effusion. Furthermore, tympanogram results showed pathologic curves in 98 cases (40.47% Type B curve and 37.30% Type C curve). In a similar study by Khayat and Dabbagh also, the otoscopic findings were varied with distorted cone of light, retraction of TM, and air bubbles. A study by Ajayan et al. conducted to study the effect of adenoidectomy with tonsillectomy in pediatric patients with OME, showed dull and retracted TM in 78.5% cases and air–fluid was seen only in 11.42% [In a study by Somayaji et al., the difference between the two techniques (one group for conventional adenoidectomy and another for microdebrider adenoidectomy) was statistically significant (These observations were similar to the study by Choi et al. to evaluate the effect of adenotonsillectomy on immediate Eustachian tube function in children with adenotonsillar hypertrophy. He observed that majority had C Type of curve. On postoperative day 2, 76% (38/50) of cases were unresolved (CC and BB types), while 24% (12/50) were normal (AA type) or resolved (CA type). There was a statistically significant difference (Similar results were observed in a study by Unlu et al. to analyze the changes in the MEP in the early period after adenoidectomy in children with adenoid hypertrophy without OME. He observed that there was a pathological decrease in the MEP 24 h after the procedure in one ear in 48 patients (75%) and bilateral Eustachian dysfunction in 38 patients (59.3%). Furthermore, Type B tympanogram was not seen in any patients, postoperatively. These changes in MEP returned to preoperative value by 7th postoperative day [The increase in hearing threshold and reduction in MEP in the immediate period could be due to temporary dysfunction of Eustachian tube due to edema or blood clots at the surgical site, especially around Eustachian tube orifice. Moreover, due to pain in the postoperative period, swallowing is reduced, and this also adds on to the cause for Eustachian tube dysfunction [In a study by Somayaji et al., there was a significant improvement in the MEP and hearing threshold at 6 weeks following surgery as seen with PTA and tympanometry. There was a complete resolution of OME in 15 out of 16 children as suggested by postoperative Type A tympanogram. Similar results were observed in a study by Tuohimaa and Palva. A similar study by Zaman and Borah also showed that there was a significant improvement in the MEP following adenoidectomy [Sandooja et al. in his study on effect of adenotonsillectomy on hearing threshold and MEP also has shown improvement in MEP and hearing threshold following surgery and hence concluded that adenoidectomy improves the Eustachian tube function and MEP by eliminating the mechanical obstruction, edema of Eustachian tube orifice due to repeated infection [Similar results were observed in a retrospective study by Enache et al. At 1 month after surgery, a normal Eustachian tube function was seen in 43.70% of the children and at 3 months after surgery, when the second reassessment was made, 109 children (91.60%) presented a total recovery of the middle ear function with a normal Eustachian tube activity [Ajayan et al., in his study, observed that 6 weeks following surgery, 55.71% of Type B tympanogram changed to Type A and 15.7% to Type C, while in 28.57%, Type B persisted. After 3 months, 65.71% of tympanogram were Type A and 8.57% were Type C. In 25.71% of subjects, Type B tympanogram persisted. It was also observed that, in all those subjects with persistent Type B tympanogram, preoperative hearing loss was higher, that is, between 40 and 50 dB [In the present study, one case (2%) had persistent OME bilaterally as suggested by persistence of Type B tympanogram and reduced MEP. This could be due to persistence of Eustachian tube dysfunction [In another study, comparing effect of tonsillectomy and adenotonsillectomy over the tubal function, they discussed that there is a transient negative middle ear pressure in the early postoperative period more after adenotonsillectomy, then adenoidectomy and least after tonsillectomy with complete resolution one month postoperatively [Cost difference between the coblation and microdebrider blade versus conventional technique is always matter of discussion in different techniques of adenoidectomy. Though cost assessment was not studied as primary outcome of the present study, coblation technique had cost more than for microdebrider or conventional techniques. Although, coblation had better results on postoperative tympanographic findings but it had more cost with less bleeding rather than conventional technique. Microdebrider technique had less cost with mostly similar results in tympanographic findings and bleeding outcomes rather than coblation technique.

PMC10764527

Author contributions

AS collected patients from outpatient clinic and was responsible for the design and analyzing data and share in writing the manuscript. AS and AN were major contributors in writing the manuscript. AS and AF analyzed and interpreted the patient data regarding the diagnosis and management of the cases. All authors read and approved the final manuscript.

PMC10764527

Funding

Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). There is no funding.

PMC10764527

Availability of data and materials

The data sets used and/or analyzed in the current study are available from the corresponding author on reasonable request.

PMC10764527

Declarations

PMC10764527

Conflict of interest

The authors declare that they have no competing interests in this section.

PMC10764527

Ethics approval and consent to participate

Consent was taken from patients before performing any operation, and they had the right to refuse at any time. The study was approved by the Research Ethics Committee of the Faculty of Medicine, Al-Azhar University. Ethics committee reference number is 8/2022ENT/231.

PMC10764527

Consent for publication

Not applicable.

PMC10764527

References

PMC10764527

Subject terms

tumor, clear cell carcinoma

REGRESSION, ENDOMETRIAL CANCER, CLEAR CELL CARCINOMA, TUMOR

Uterine clear cell carcinoma (UCCC) is a relatively rare endometrial cancer. There is limited information on its prognosis. This study aimed to develop a predictive model predicting the cancer-specific survival (CSS) of UCCC patients based on data from the Surveillance, Epidemiology, and End Results (SEER) database between 2000 and 2018. A total of 2329 patients initially diagnosed with UCCC were included in this study. Patients were randomized into training and validation cohorts (7:3). Multivariate Cox regression analysis identified that age, tumor size, SEER stage, surgery, number of lymph nodes detected, lymph node metastasis, radiotherapy and chemotherapy were independent prognostic factors for CSS. Based on these factors, a nomogram for predicting the prognosis of UCCC patients was constructed. The nomogram was validated using concordance index (C-index), calibration curves, and decision curve analyses (DCA). The C-index of the nomograms in the training and validation sets are 0.778 and 0.765, respectively. Calibration curves showed good consistency of CSS between actual observations and nomogram predictions, and DCA showed that the nomogram has great clinical utility. In conclusion, a prognostic nomogram was firstly established for predicting the CSS of UCCC patients, which can help clinicians make personalized prognostic predictions and provide accurate treatment recommendations.

PMC10247799

Introduction

tumor, clear cell carcinoma

TUMOR, CLEAR CELL CARCINOMA, MULTIPLE CANCER

Uterine clear cell carcinoma (UCCC) is a relatively rare endometrial cancerDue to the rarity of UCCC, there is limited information on its biology and pathogenesisAccurately predicting the survival probability of an individual tumor patient may change the pattern of medical practice and aid in clinical decision-making. As a risk and benefit assessment tool that can provide physicians and patients with more objective and accurate information, clinical prediction models have been increasingly used in recent years. The nomogram is a statistical-principles-based predictive tool that integrates key predictors and is widely used to quantify risk and assess prognosis in multiple cancers

PMC10247799

Results

PMC10247799

Validation of the nomogram

The C-index of the nomogram in the training set and validation set is 0.778 (95% CI 0.758–0.798) and 0.765 (95% CI 0.743–0.787), respectively, indicating that the nomogram has good prediction accuracy. Calibration curve analysis showed that the survival rate predicted by the nomogram was in good agreement with the actual survival rate, indicating that the nomogram had better predictive performance (Fig. Calibration curves of the nomogram. (Decision curves of the nomogram. (

PMC10247799

Discussion

tumor

TUMOR, METASTASIS

In this study, we developed a nomogram for predicting CSS in UCCC patients based on eight predictors of patient’s age, tumor size, SEER stage, surgery, number of lymph nodes detected, lymph node metastasis, radiotherapy and chemotherapy. The predictors included in the model can be easily obtained from clinical practice. Validation of the model using different statistical methods demonstrates its excellent performance. Furthermore, DCA demonstrated that our nomogram predicted survival with better clinical benefit and utility than the conventional staging system.UCCC is rare and considered to be prone to myometrial invasion, lymphovascular invasion, lymph node metastasis and extrauterine metastasis, so most of them were diagnosed at a later stage. Due to its rarity, there are few studies on UCCC, and these studies are usually single-center, small-sample studiesPrevious studies indicated that age, tumor size and pathologic stage might be important factors affecting the prognosis of UCCCThis is the first study to established a prognostic model for UCCC. Based on the SEER database system, this study integrated the relevant clinicopathological factors and treatment patterns affecting the prognosis of UCCC patients into a nomogram, thereby successfully constructing a predictive model consistent with the condition of UCCC patients. Compared with the SEER staging system (surrogate for traditional FIGO staging), it has the advantages of being comprehensive, intuitive, more accurate and convenient. The multi-center large sample also provides a guarantee for the credibility of the final model.This study has several limitations. First, SEER database lacks detailed information about chemotherapy and radiotherapy, and there is no data about surgical margins, extent of pelvic lymph node dissection, and lymph node invasion, which may affect the prognosis of UCCC. Second, the nomogram model is only verified internally. It is necessary to use cohort and prospective randomized clinical trials from other countries for external verification to confirm its performance. Third, there may be selection bias due to the nature of retrospective analysis.In conclusion, we developed a nomogram for predicting CSS in UCCC patients based on the SEER database, which can help clinicians make individualized prognosis predictions and provide accurate treatment recommendations.

PMC10247799

Methods

PMC10247799

Patient selection

tumor, death

DISEASES, TUMOR, PRIMARY TUMORS, DISEASE, ONCOLOGY

Data on UCCC patients registered between 2000 and 2018 were extracted from the SEER database using SEER* Stat (version 8.4.0.1) software. Inclusion criteria included: (1) pathologically confirmed UCCC, coded as 8310/3 according to the International Classification of Diseases for Oncology, Third Edition (ICD-O-3); (2) primary site included corpus uteri/uterus not specified; (3) age ≥ 18 years old. Exclusion criteria included: (1) multiple primary tumors; (2) incomplete clinicopathological data; (3) lost to follow-up or follow-up less than 1 month.Extracted data included: gender, age, race, marital status, tumor location, tumor size, year of diagnosis, pathological grade, SEER stage, AJCC TNM staging (7th edition), surgery, chemoradiotherapy, follow-up time and survival. The SEER stage (local, regional, and distant) was used to classify the extent of the disease as a surrogate for the traditional FIGO staging. The primary endpoint of the study was cancer-specific survival (CSS), defined as the time from diagnosis to death from UCCC or time to last follow-up. The optimal cutoff values for continuous variables were determined using the "X-Tile" software (Yale School of Medicine, CT, USA), converting age, tumor size, number of lymph nodes dissected into categorical variables.

PMC10247799

Statistical analysis

REGRESSION

The final included UCCC patients were randomly assigned to the training set and the validation set in a 7:3 ratio using R software. The training set was used to build a risk prediction model and to construct a nomogram to predict a patient's CSS at 5 and 10 years. Validation groups are used for internal validation. For comparison of count data between groups, chi-square or Fisher's exact test is used; for comparison of multi-category variables between groups, chi-square test or Fisher's exact probability method for R*C tables is used. Continuous variables were compared using the t-test or the Mann–Whitney U test. In the training group, univariate and multivariate analyses were performed by Cox proportional hazards regression models to identify independent prognostic factors associated with CSS. The patient characteristics with

PMC10247799

Acknowledgements

We acknowledged the contributions of the Surveillance, Epidemiology, and End Results (SEER) Program registries for creating and updating the SEER database.

PMC10247799

Author contributions

This study was designed by W.L.C and J.C. Data extraction, statistical analysis and interpretation of data were performed by W.L.C., R.M.W. and Y.Z. All authors were involved in drafting and revision of the manuscript and approved the final version to be published.

PMC10247799

Data availability

The data that support the findings of this study are openly available in software package SEER*Stat 8.4.0.1 (

PMC10247799

Competing interests

The authors declare no competing interests.

PMC10247799

References

PMC10247799

Background:

Remimazolam is a novel, ultrashort-acting benzodiazepine that can be antagonized by flumazenil. This study aimed to determine whether remimazolam-based anesthesia with flumazenil provides a more rapid emergence than propofol-based anesthesia in older patients undergoing spinal surgery.

PMC10659722

Methods:

SECONDARY

This was a prospective, single-blind, randomized controlled trial. Forty-four patients > 75 years old who had undergone spinal surgery were enrolled in this study. They were randomly assigned to the remimazolam or propofol group (1:1) using a computer randomization system stratified by age and body weight. For anesthesia induction and maintenance, remifentanil was administered at a defined dose in both groups, and remimazolam or propofol was adjusted to maintain the bispectral index or state entropy monitoring within 40–60. All anesthetics were discontinued simultaneously after the postoperative X-ray and 0.5 mg flumazenil was administered to the remimazolam group. The primary outcome was extubation time after discontinuing anesthesia, and the secondary outcomes were time to eye opening, obeying commands, and achieving a white fast-track score (WFTS) of 12.

PMC10659722

Results:

Thirty-nine patients were finally analyzed: remimazolam group (n = 20), propofol group (n = 19). There were no significant differences in intraoperative variables, such as operative time, anesthesia time, and patient background, between the 2 groups. Extubation times were significantly shorter in the remimazolam group than in the propofol group (4 vs 8 minutes,

PMC10659722

Conclusion:

Remimazolam-based anesthesia with flumazenil resulted in a faster emergence than propofol-based anesthesia in older patients undergoing spinal surgery.

PMC10659722

1. Introduction

ADVERSE EVENTS, NEUROLOGICAL COMPLICATION

Delayed emergence from general anesthesia interferes with operating room (OR) management and increases adverse events such as delayed recovery of airway reflexes.Spinal surgery, which often involves older patients, requires intraoperative motor-evoked potential (MEP) monitoring to reduce perioperative neurological complications, which limits the use of inhaled anesthetics and muscle relaxants that interfere with MEP monitoring. Therefore, total intravenous anesthesia using propofol is recommended for anesthesia maintenance, and sufficient anesthesia depth must be maintained to achieve immobility without muscle relaxants during spinal surgery.Propofol is primarily metabolized and excreted by the liver and kidneys. Therefore, older patients are likely to have delayed emergence and require smaller doses than younger patients.Remimazolam is a new benzodiazepine that can be administered continuously and antagonized by flumazenil. This new intravenous anesthetic is an ultra-short-acting agent that enables more rapid induction and emergence than the conventional benzodiazepine midazolam. It has a similar structure to midazolam; however, it is rapidly metabolized by tissue esterases, primarily in the liver, and its metabolites are inactive.The purpose of this study was to compare the state of emergence in older patients who underwent spinal surgery under general anesthesia using remimazolam and propofol and to determine whether remimazolam-based anesthesia provides a more rapid emergence than propofol-based anesthesia. Since remimazolam is approved for general anesthesia only in Japan and Korea, and studies on the state of emergence from general anesthesia using this drug are still few, especially limited to older patients undergoing spinal surgery, we believe it is significant to report the results of this study using remimazolam.

PMC10659722

2. Methods

PMC10659722

2.1. Study design

This prospective, multicenter, single-blind, randomized controlled study was conducted at Hiroshima University Hospital and JA Hiroshima General Hospital (a regional hospital). The study was approved by the Ethics Committee of Hiroshima University on November 25, 2020 (C-306) and the Ethics Committee of JA Hiroshima General Hospital on February 22 2022 (21–73) and registered in the UMIN Clinical Trials Registry database (UMIN000042568, first registration date 26/11/2020). Written informed consent was obtained from all patients, and all study-related procedures were performed in accordance with the Declaration of Helsinki.

PMC10659722

2.2. Participants

liver dysfunction, dementia

OBESE, SPINAL TUMORS

Patients who met the inclusion criteria underwent spinal surgery including laminoplasty, laminectomy, posterior spinal fusion, and resection of spinal tumors.The inclusion criteria were as follows: >75 years old, American Society of Anesthesiologists (ASA) physical status classification 1 to 3, and written informed consent. The exclusion criteria were as follows: liver dysfunction (Child-Pugh class B or C), renal replacement therapy, morbidly obese (BMI: body mass index ≥ 35), dementia, atypical surgery, and contraindications for use of anesthetics.

PMC10659722

2.3. Randomization and masking

The patients underwent single-blind randomization (1:1) into 2 groups (remimazolam group - group R, or propofol group - group P) via the Research Electronic Data Capture (REDCap) computer randomization system stratified by age (75–79 years old or ≥ 80 years old) and body weight (<60 kg or ≥ 60 kg). Patients and operators were blinded to group identification, whereas the attending anesthesiologist could not be blinded to group identification because of the markedly different appearance of the 2 anesthetics.

PMC10659722

2.4. General anesthesia protocol

All patients were randomly managed by staff anesthesiologists at each hospital. None of the patients received any premedication. Standard monitoring included electrocardiography, noninvasive blood pressure or arterial blood pressure monitoring, pulse oximetry, capnography, electroencephalogram-based monitoring using the bispectral index (BIS, Aspect Medical Systems, Newton, MA) at Hiroshima University Hospital or Spectral Entropy (GE Healthcare, Helsinki, Finland) at JA Hiroshima General Hospital, and neuromuscular monitoring via train-of-four monitoring.General anesthesia was induced with a continuous intravenous infusion of remifentanil at 0.25 µg/kg/min, followed by continuous infusion of remimazolam at 12 mg/kg/h in group R or target-controlled infusion of propofol with an initial target of 3 µg/mL in group P. Remifentanil doses were calculated based on actual body weight for patients with a BMI < 25 and ideal body weight for patients with BMI ≥ 25. Other anesthetics were calculated based on actual body weight. Rocuronium was administered at 0.6 mg/kg only for intubation. Following anesthesia induction, the ventilator settings were adjusted to maintain an oxygen saturation (SpOIn both groups, for anesthesia maintenance, remifentanil was maintained at approximately 0.25 µg/kg/min and tapered to 0.05 µg/kg/min after ropivacaine wound infusion before skin closure. Remimazolam or propofol was adjusted to keep the BIS or state entropy values in the range of 40 to 60 after the patients lost consciousness.The criteria for extubation are as follows: SpOWe measured the following times: from discontinuing administration of anesthetics to eye-opening, obeying commands, extubation, and achieving a white fast-track score (WFTS) of 12. The WFTS was used to evaluate the ability to be discharged from the OR (see Supplementary Table S1 online,

PMC10659722

2.5. Outcome measures

ADVERSE EVENTS, SECONDARY

The primary outcome was the elapsed time from the discontinuation of anesthesia to extubation. Extubation time can be an indicator of the emergence of the patient from general anesthesia, as extubation requires the recovery of respiratory function and consciousness.The secondary outcomes were the elapsed time from the discontinuation of anesthesia to eye opening, obeying commands, and achieving a WFTS of 12.Other measured outcomes included the duration of surgery and anesthesia, dose of each anesthetic, frequency of post-anesthetic adverse events, and WFTS before leaving the OR.

PMC10659722

2.6. Sample size

Previously, we found that the average time to extubation at our institution was 17 ± 5 minutes in 37 patients who were > 75 years old and underwent spinal surgery under propofol-remifentanil anesthesia from April 2019 to March 2020 in Hiroshima University Hospital.The G*power 3.1.0 program (We used a type 1 error of α = 0.05, and a power of 0.80 to calculate sample sizes.Considering a dropout rate of 15 %, 22 patients per group were enrolled in this study.

PMC10659722

2.7. Statistical analyses

All data are expressed as interquartile range, or numbers (%). Continuous variables were compared using the Mann–Whitney U test, and the Fisher exact test was used to compare categorical variables. Statistical significance was set at

PMC10659722

3. Results

thirty-nine, hypotension

The CONSORT flow diagram of this study is shown in Figure The CONSORT flow diagram.Forty-four patients were enrolled between January 2021 and September 2022 and were randomly allocated to either group R (n = 22) or group P (n = 22). Following randomization, 2 patients declined to participate. One patient was unable to receive the allocated intervention because there was no anesthesiologist available to conduct this study because of emergency surgeries. Thereafter, one additional patient in group P discontinued the allocated intervention because of severe hypotension during anesthesia induction. Excluding 1 patient who deviated from the protocol, thirty-nine patients were finally analyzed in this study (group R, n = 20; group P, n = 19).Patient demographics revealed no significant differences in background characteristics between the 2 groups (Table Patient characteristics.IQR = interquartile range.Intraoperative variables.IQR = interquartile range.The emergence time (time to extubation) was significantly shorter in group R than in group P (4 minutes vs 8 minutes, Emergence variables.Values are expressed as median [interquartile range].WFTS = white fast-track score.Comparison of extubation times for propofol and remimazolam anesthesia.Values are expressed as the number of cases.Secondary outcomes were also shorter in group R. The time to eye-opening, obeying commands, and achieving a WFTS of 12 were also significantly shorter in group R (White fast-track score before leaving the OR.OR = operation room, SpO

PMC10659722

4. Discussion

re-sedation, emesis, pain

ADVERSE EVENTS

This study showed that the time to extubation, eye opening, obeying commands, and achieving a WFTS score of 12 were all significantly shorter under remimazolam-based anesthesia with flumazenil than under propofol-based anesthesia in older patients who underwent spinal surgery. There were no prolonged extubation (defined as 15 minutes or longer)Extubation time is an important factor in emergence from general anesthesia. Prolonged extubation decreases OR efficiency, including case turnover and use of OR time, and increases variable OR costsThe type of anesthetic used can affect the time of emergence. Remimazolam is a short-acting benzodiazepine that acts on gamma-aminobutyric acid (GABA)Both anesthetics are short-acting; however, remimazolam is less accumulative. Notably, the GABAergic effects of remimazolam can be antagonized by flumazenil. This suggested that remimazolam can provide a more rapid emergence than propofol, which does not antagonize antidotes. However, remimazolam anesthesia takes longer to emerge than propofol anesthesia.The emergence status was assessed using the WFTS. We have no post-anesthesia care unit, and take patients from the OR directly to the less extensively monitored wards. Therefore, we used the white fast-track scoring system incorporating the evaluation of emesis and pain in the modified Aldrete scoring system. This is commonly used for discharge criteria from the post-anesthesia care unit to postsurgical wards, to measure the ability for discharge from the OR.In spinal surgery with MEP monitoring, the influence of benzodiazepines on MEP is considered similar to that of propofol. Although studies on remimazolam are few, they are unlikely to interfere with MEP monitoring.This study had several limitations. First, remimazolam and propofol were adjusted based on electroencephalogram monitoring; however, minimal doses of both anesthetics were not established. We did not excessively reduce the dose to avoid intraoperative arousal. Therefore, it is possible that both propofol and remimazolam could have been further reduced.Second, flumazenil (0.5 mg) was administered simultaneously as the discontinuation of anesthetic administration in all patients; however, an adequate dose and timing for flumazenil administration have not yet been established. There have been reports that 0.2–0.4 mg flumazenil administration following remimazolam anesthesia in older patients undergoing transcatheter aortic valve implantation did not cause re-sedation, and that 0.5 mg flumazenil administered immediately after remimazolam anesthesia did not cause any adverse events. In this study, we set up a 0.5 mg single-dose flumazenil protocol based on these reports.In conclusion, we investigated the state of emergence from remimazolam-based anesthesia in the older patients > 75 years old who underwent spinal surgery. This study showed that remimazolam-based anesthesia with flumazenil resulted in a significantly faster emergence than propofol-based anesthesia.

PMC10659722

Acknowledgments

We also would like to thank Editage (

PMC10659722

Abbreviations:

Kondo T

gamma-aminobutyric acidmotor evoked potentialsoperating roomoxygen saturationwhite fast-track scoreThe datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.Supplemental Digital Content is available for this article.The authors have no conflicts of interest to disclose.This study was supported in part by the Japan Society for the Promotion of Science KAKENHI, grant number 23K08361, for scientific research (T.K.)How to cite this article: Toyota Y, Kondo T, Oshita K, Haraki T, Narasaki S, Kido K, Kamiya S, Nakamura R, Saeki N, Horikawa YT, Tsutsumi YM. Remimazolam-based anesthesia with flumazenil allows faster emergence than propofol-based anesthesia in older patients undergoing spinal surgery: A randomized controlled trial. Medicine 2023;102:46(e36081).

PMC10659722

References

PMC10659722

Introduction

COMPLICATIONS

ureteral stents have common complications like ureteral stent-related symptoms (SRSs). This study investigated the effectiveness of tadalafil compared to mirabegron and solifenacin combination therapy in patients with ureteral SRSs after double-J (DJ) stent insertion.

PMC10620325

Methods

pain

this double-blind, randomized clinical trial used consecutive random sampling in participants with SRSs after double-J stent insertion. The study was conducted at four different hospitals in Makassar, Indonesia, from July to December 2020. Ureteral stent-related morbidity indices which analyzed include urinary symptoms, pain, general health, quality of work, and sex scores. All of the indices were measured by ureteral symptom score questionnaire for the first, second, third, and fourth weeks after drug consumption, either tadalafil 10 mg/day (group A, n=25) and a combination of mirabegron 25 mg/day and solifenacin 5 mg/day (group B, n=28).

PMC10620325

Results

pain

before the treatment procedure, the groups were comparable in age, gender, body mass index, DJ stent procedures, type, and indication. In general, the score in all parameters declined over the follow-up time for both groups. Group A had a lower urinary symptom score than group B at week III and week IV (all p-value < 0.001). In addition, group A had a lower pain score, general condition, work activity, and other complaints than group B at week II, week III, and week IV (all p-value <0.001). The sexual activity score is comparable between the group, except in week I.

PMC10620325

Conclusion

according to our results, we suggest tadalafil to minimize stent-related urinary symptoms and improve general health in patients with double J stent.

PMC10620325

Introduction

urinary complaints, pain

SIDE EFFECTS

A ureteral stent is a tool to facilitate the flow of urine from the kidney to the bladder that is disturbed due to obstruction. Ureteral stents have an important role in the temporary drainage of the upper urinary tract and are a frequently performed procedure in endourological surgery [Given the large number of patient complaints, a questionnaire system was developed to evaluate morbidity and side effects after DJ stent placement. The Ureteral Stent Symptoms Questionnaire (USSQ) is the gold standard questionnaire to evaluate the morbidity and side effects of post-DJ stent placement. This questionnaire evaluated complaints that asked about urinary complaints, pain degrees, general health status, work activities, sexual activities, and accompanying complaints that cause discomfort on the subject [Along with technological advances and modifications of ureteral stents that continue to be developed to date, various studies to overcome the side effects associated with symptoms after DJ stent placement include modification of stent design, medication, stent position, stent coating, and intravesical therapy [Several previous studies have shown the efficacy of these three drugs in improving SRSs, either single or in combination. Side effects obtained from using this drug are also minimal and well-tolerated [

PMC10620325

Discussion

sexual dysfunction, complaints of urinary symptoms, complaints of sexual activity, pain

This study revealed that male patients comprised more than 70% of the occurrence in both group and the majority (52.84%) in the age of 26-45 years. The findings of this study are comparable with those of Pansota Post-DJ-stent patients who experienced SRSs were divided into 2 groups and treated with Tadalafil 10 mg/day or a combination of mirabegron 25 mg/day + solifenacin 5 mg/day. Both groups were then observed and assessed using the USSQ questionnaire. According to the study's findings, the tadalafil therapy group exceeded the mirabegron and solifenacin combination group in treating all SRSs.The findings of this study suggest that treatment with tadalafil 10 mg/day for three weeks in patients having DJ-stents implanted can lessen complaints of urinary symptoms, pain, complaints of general condition, complaints of working activity, complaints of sexual activity, and other complaints. The most effective treatment for patients following DJ-stent insertion can reduce pain complaints using tadalafil 10 mg/day for three weeks. The findings of this study are consistent with those of Haghro Tadalafil 10 mg in this study can reduce urinary symptoms by 19.08 ± 4.21 points in three weeks. Similar findings were also reported by Bhattar Similar to the efficacy of tadalafil in the present study, the combination of mirabegron 25 mg/day + solifenacin 5 mg/day for three weeks can improve the urinary symptoms, pain, general condition, working activity, and other complaints. However, there was a significant in allegations of sex activity. In a study conducted by Abrams Based on previous studies, researchers have not found a study comparing the effectiveness of tadalafil 10 mg/day and the combination of mirabegron 25 mg/day + solifenacin 5 mg/day in patients with SRSs. The limitations of this study were that some of the samples in this study were sexually inactive such as not having a partner, old age, and a partner died, as well as the uneven timing of starting sexual activity so that it affected the results on the USSQ questionnaire and the duration of observation in this study lasted for 4 weeks so that only can assess the short-term effect of drug administration on complaints of SRSs. There are other several limitations such as a small sample size, and no comparison after stent removal. The variations and bias in the USSQ questionnaire's five parts have a logical correlation to each other; for example, the patients who had stent-related urinary symptoms have more chance for sexual dysfunction, and the patients who had urinary symptoms, pain, and inappropriate general health had bad quality and quantity of job.

PMC10620325

Conclusion

Tadalafil and a combination of mirabegron and solifenacin improved the SRSs in three weeks. However, additional benefits can be achieved using tadalafil 10 mg. This may imply the single use of tadalafil 10 mg in overcoming SRSs is more considered than the combination therapy, particularly in patients with drug compliance problems. There is a need for further research on the effectiveness of single groups and combination groups with more varied types and doses of drugs, screening for more specific sample characteristics so that the results of the questionnaire conducted can be more homogeneous, and observations with a larger number of samples and a more extended study period to determine short-term and long-term effects and evaluation in therapy in this study.

PMC10620325

Competing interests

The authors declare no competing interests.

PMC10620325

Authors' contributions

Conceived and designed the analysis: Tjia Adynata Ciayadi, Muhammad Asykar Palinrungi, Khoirul Kholis, Syakri Syahrir, Syarif Syarif, and Abdul Azis; data collection: Tjia Adynata Ciayadi; data analysis: Tjia Adynata Ciayadi and Joko Hendarto; wrote the paper: Tjia Adynata Ciayadi; final approval: Muhammad Asykar Palinrungi, Khoirul Kholis, Syakri Syahrir, Syarif Syarif, and Abdul Azis. All the authors read and approved the final version of this manuscript.

PMC10620325

Purpose

TYPE 2 DIABETES

To assess the magnitude and durability of the metabolic benefits by simplification of complex insulin treatments in patients with type 2 diabetes inadequately controlled by a full basal-bolus insulin regimen. Herein we report the results of the scheduled 2-year extension of the BEYOND trial.

PMC10850008

Methods

Originally, 305 participants with inadequate glycemic control (HbA1c > 7.5%) were randomly assigned to intensification of basal-bolus insulin regimen (

PMC10850008

Results

SD

Fifty-five percent of patients completed the study in the two comparison arms. Compared with patients randomized to basal-bolus, patients of the other groups experienced non statistically different reductions in HbA1c level according to either an intention-to-treat analysis (−0.8 ± 1.1%, −0.7 ± 1.1%, and −1.3 ± 1.1%, mean ± SD, fixed-ratio, gliflo-combo and basal bolus, respectively) or per-protocol analysis (−1.2 ± 1.0%, −1.2 ± 1.1%, and −1.3 ± 1.0%, respectively). The final HbA1c level (per protocol) was 7.2 ± 0.8%, 7.3 ± 0.9%, and 7.5 ± 0.9%, respectively (

PMC10850008

Conclusion

TYPE 2 DIABETES

Simplification of complex insulin regimen may be a durable option in at least one-half of patients with type 2 diabetes.

PMC10850008

Clinical trial registration

Clinical trial registration no. NCT04196231, clinicaltrials.gov.

PMC10850008