Quality of Recovery of Remimazolam Versus Sevoflurane in Transurethral Bladder Resection.

Not Applicable

Completed

• Conditions: Quality of Recovery
• Interventions: Drug: Remimazolam; Drug: Sevoflurane

• Registration Number: NCT05356091
• Lead Sponsor: Kangbuk Samsung Hospital

Brief Summary

This study was designated to investigate the quality of recovery after transurethral bladder resection. Because, patients undergoing transurethral bladder resection are mostly old age, and because of catheter-related bladder discomfort are common after transurethral bladder resection, study on the quality of recovery after transurethral bladder resection seems to be meaningful. In general, sevoflurane is commonly used as an anesthetic agent for general anesthesia of transurethral bladder resection. The purpose of this study is to investigate whether remimazolam is not inferior to sevoflurnane in terms of quality of recovery after transurethral bladder resection.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-24
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-05-02
• Study Start: 2022-12-02
• Primary Completion: 2023-02-24
• Study Completion: 2023-02-24
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• adult patients aged from 19 years
• Americaln Society of Anesthesiologist's class I, II, and III
• scheduled to undergo elective transurethral bladder resection under general anesthesia

Exclusion Criteria

• refuse to participate in the study
• cannot read, or sign the consent form (e.g., iliterate, foreigner, eye disease)
• history of allergy to benzodiazepines
• decreased liver, kidney, or heart function
• pregnant women or breastfeeding patients
• history of drug or alcohol abuse
• obesity (body mass index > 30kg/m2)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam	Remimazolam	General anesthesia using remimazolam
Sevoflurane	Sevoflurane	General anesthesia using sevoflurane

Primary Outcome Measures

Name	Time	Method
Quality of recovery -15 score at postoperative day 1	postoperative day 1	Quality of recovery-15 questionnaire, which consists 15 questions. The score ranges from 0 to 150. The higher the score, the better the quality of recovery.

Secondary Outcome Measures

Name	Time	Method
Catheter related bladder discomfort	5 minutes, and 1 hour after post-anesthesia circuit unit arrival.	Catheter related bladder discomfort is assessed as none, mild, moderate and severe.

Trial Locations

Locations (1)

Eunah Cho; 🇰🇷 Seoul, Korea, Republic of