NCT05280236

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

2.1 years

First QC Date

March 6, 2022

Last Update Submit

July 4, 2024

Conditions

Adult Patients 19 or Older Scheduled for Elective Arthroscopic Meniscectomy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Propofol

ACTIVE COMPARATOR

Patients receiving general anesthesia with propofol-based total intravenous anesthesia

Drug: Propofol TIVA

Remimazolam

EXPERIMENTAL

Patients receiving general anesthesia with remimazolam-based total intravenous anesthesia

Drug: Remimazolam TIVA

Interventions

Propofol TIVADRUG

Patients will receive propofol-based TIVA with propofol and remifentanil TCI (target controlled infusion)

Propofol
Remimazolam TIVADRUG

Patients will receive remimazolam-based TIVA with remimazolam infusion and remifentanil TCI

Remimazolam

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2022

First Posted

March 15, 2022

Study Start

March 14, 2022

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

July 8, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)