Comparison of Quality of Recovery Between Remimazolam and Propofol Anesthesia in Patients Undergoing Arthroscopic Meniscectomy

This study aims to compare quality of recovery after surgery and anesthesia between patients undergoing arthroscopic meniscectomy under general anesthesia with either propofol or remimazolam based total intravenous anesthesia. This study is a randomized trial with a 50% probability of being assigned to either group. Randomization will be done by an anesthesiologist not involved in anesthesia or postoperative outcome assessment. Patients and the investigator in charge of postoperative outcomes assessment will be blinded to group allocation.

Study Overview

• Status: Completed
• Conditions: Adult Patients 19 or Older Scheduled for Elective Arthroscopic Meniscectomy
• Intervention / Treatment: Drug: Propofol TIVA; Drug: Remimazolam TIVA

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University Health System, Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients 19 or older, ASA class I~III,
• scheduled for arthroscopic meniscectomy under general anesthesia and eligible for LMA use.

Exclusion Criteria:

• Patient refusal,
• patients unable to read consent form, active URI or uncontrolled asthma,
• pneumonia,
• history of allergies to propofol or benzodiazepines,
• decreased liver or kidney function, heart failure of ejection fraction<55%,
• pregnant or breastfeeding patients,
• history of substance abuse/addiction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol; Patients receiving general anesthesia with propofol-based total intravenous anesthesia	Drug: Propofol TIVA; Patients will receive propofol-based TIVA with propofol and remifentanil TCI (target controlled infusion)
Experimental: Remimazolam; Patients receiving general anesthesia with remimazolam-based total intravenous anesthesia	Drug: Remimazolam TIVA; Patients will receive remimazolam-based TIVA with remimazolam infusion and remifentanil TCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery (QoR)-40 questionnaire	Quality of recovery assessed with the QoR-40 questionnaire, which is a widely-used, self-rated, self-completed questionnaire for postoperative patients.	Postoperative 24 hours

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: March 6, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 4-2021-1803

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