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NCT05320016 Clinical Trial

Effects of Remimazolam on Quality of Recovery After Ambulatory Surgery

Quality of Recovery Clinical Trial

Official title:
Effects of Remimazolam Combined With Remifentanil on Quality of Recovery After Ambulatory Hysteroscopic Surgery: a Prospective, Observational Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05320016
Other study ID # B-2109-708-309
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date December 31, 2021

Study information
Verified date April 2022
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender Female
Age group 19 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Remimazolam
Effects of remimazolam on quality of recovery scores after ambulatory hysteroscopic surgery

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyunggi-do

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of recovery the translated Korean version of 15-item Quality of Recovery scale (QoR-15K) 24 hours after ambulatory hysteroscopic surgery
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