Effects of Remimazolam on Quality of Recovery After Ambulatory Surgery

Completed

• Conditions: Quality of Recovery; Day Surgery; Patient Outcome Assessment; Remimazolam

• Registration Number: NCT05320016
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

Remimazolam is a novel ultra-short acting benzodiazepine with rapid onset of effects, short maintenance and faster recovery time. Due to its recent development, few studies have investigated the effect of remimazolam on postoperative recovery mainly focusing on physiologic endpoints, recovery time and possible adverse events. Although these parameters are crucial and need evaluation, the investigators ignore quality of recovery from participant's perspective. For this purpose, various measurment tools have been developed for psychometric evaluation of QoR score.

Detailed Description

To date, there has not been a study investigating the impact of remimazolam on quality of recovery (QoR). This study evaluates the effect of remimazolam on QoR of participants undergoing general anesthesia using remimazolam-remifentanil total intravenous anesthesia (TIVA) for hysteroscopy as day surgery basis. Herein, the investigators used the translated Korean version of the 15-item Quality of Recovery-15 (QoR-15K) questionnaire, which was previously validated in Korean surgical participants.

Study Timeline

• Study Start: 2021-11-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted: 2022-03-30
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-06
• Last Update Submitted: 2022-04-06
• Study First Posted: 2022-04-11
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

• Adult woman scheduled for ambulatory gynecological surgery under general anesthesia
• American Society of Anesthesiology grade 1 or 2

Exclusion Criteria

• Underlying diseases: liver, kidney, brain nervous system, glaucoma
• Patients with BMI greater than 30 and less than 18.5
• Patients diagnosed with sleep apnea
• Alcohol or drug dependent patients
• Patients with severe or acute respiratory failure
• Lactose intolerance
• Dextran 40 hypersensitivity
• Patients in shock or coma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of recovery	24 hours after ambulatory hysteroscopic surgery	the translated Korean version of 15-item Quality of Recovery scale (QoR-15K)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyunggi-do, Korea, Republic of