Effects of Remimazolam on Quality of Recovery After Ambulatory Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Patient Outcome Assessment; Quality of Recovery; Day Surgery; Remimazolam
• Intervention / Treatment: Drug: Remimazolam

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 Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyunggi-do
    • Seongnam-si, Gyunggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Adult woman scheduled for ambulatory gynecological surgery under general anesthesia

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Sang-Hwan Do, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: B-2109-708-309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No