Comparison of Remimazolam and Propofol for Recovery of Ambulatory Upper Airway Surgery

July 11, 2024 updated by: Se-Hee Min, Chung-Ang University Gwangmyeong Hospital

Comparison of Remimazolam Versus Propofol-based General Anesthesia on Postoperative Quality of Recovery in Patients Undergoing Ambulatory Upper Airway Surgery: a Randomized Controlled Trial

The purpose of this study is to compare the effects of remimazolam and propofol on postoperative recovery time, complications, and safety in patients undergoing ambulatory upper airway surgery under general anesthesia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients scheduled for ambulatory upper airway (including nasal cavity, oral cavity, pharynx, larynx) surgery and who agree to participate in the study will be randomly assigned to the Remimazolam group and the Propofol group. In the Remimazolam group, general anesthesia is induced and maintained by continuous infusion of remimazolam and remifentanil. Once the surgery is completed, general anesthesia is recovered with flumazenil. In the Propofol group, general anesthesia is induced and maintained by continuous infusion of propofol and remifentanil using a target concentration controlled infusion method. In both groups, rocuronium is used for neuromuscular blokade, and sugammadex is used for reversal of neuromuscular blockade.

When the surgery is completed, recovery time, occurrence of adverse events, and anesthesia recovery indicators are examined in 3 stages: in the operating room, while staying in the post-anesthesia care unit(PACU), and while staying in the day surgery center.

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gwangmyeon-si
      • Gyeonggi-do, Gwangmyeon-si, Korea, Republic of, 14353
        • Recruiting
        • ChungAng University Gwangmyeong Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients (age 19 or older) undergoing ambulatory upper respiratory tract (nasal cavity, oral cavity, pharynx, larynx) surgery under general anesthesia
  • American Society of Anesthesiologists physical class classification I, II, and III

Exclusion Criteria:

  • Patients who refused to participate in the study
  • Pregnant patients
  • Patients with a history of hypersensitivity to drugs or additives used during surgery
  • Patients with acute narrow-angle glaucoma
  • Alcohol or drug dependent patients
  • Patients with Child-Pugh class C liver dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remimazolam group
General anesthesia is induced by continuously injecting remimazolam (6 mg/kg/h) and remifentanil (2-6 ng/ml, target concentration controlled infusion) through an infusion pump. Afterwards, when the patient loses consciousness, rocuronium 0.6 mg/kg is injected for endotracheal intubation, and anesthesia is maintained with remimazolam (1-2 mg/kg/hr) and remifentanil after endotracheal intubation. When the surgery is completed, all anesthetic drugs being administered are stopped, and general anesthesia is terminated with flumazenil and sugammadex.
Drug: Remimazolam
General anesthesia is induced and maintained by continuous infusion of remimazolam and remifentanil, and recovered with flumazenil.
Other Names:
  • Byfavo
Active Comparator: Propofol group
General anesthesia is induced by continuously injecting propofol (2-6 mg/ml, target concentration controlled injection) and remifentanil (2-6 ng/ml, target concentration controlled injection) using a TCI infusion pump. Afterwards, when the patient loses consciousness, rocuronium 0.6mg/kg is injected for endotracheal intubation, and anesthesia is maintained with propofol and remifentanil after endotracheal intubation. When the surgery is completed, all anesthetic drugs being administered are stopped, and general anesthesia is terminated through sugammadex.
Drug: Propofol
General anesthesia is induced and maintained by continuous infusion of propofol and remifentanil.
Other Names:
  • Fresofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fit-for-discharge time
Time Frame: 15 minutes after surgery
Evaluated on a scale of 0 to 10 through the Modified Post Anesthetic Discharge Scoring System (MPADSS); a score of 9 or higher meets the discharge criteria.
15 minutes after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to eye opening, time to extubate, time to postanesthetic care unit (PACU) transfer
Time Frame: 1 minute
Measured at operating room, using a timer from the end of surgery
1 minute
postanesthetic care unit (PCAU) stay time, Day surgery center stay time
Time Frame: 5 minutes
Measured from entering to exiting each units
5 minutes
Incidence of adverse events
Time Frame: 6 hours
Including desaturation, laryngospasm, hypotension, bradycardia, hemodynamic agent administration, emergence agitation, headache, dizziness, somnolence, cough, shivering, postoperative nausea & vomiting
6 hours
Postoperative pain score
Time Frame: 6 hours
11-point NRS (0-10); for the worst pain
6 hours
modified Observer's Alertness/Sedation Scale (MOAA/S) at PACU arrival
Time Frame: 30 minutes
Evaluated on a scale of 0 to 5
30 minutes
modified Aldrete score at PACU arrival
Time Frame: 30 minutes
Evaluated on a scale of 0 to 10
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung-Ang University Gwangmyeong Hospital

Investigators

  • Study Chair: Se-Hee Min, Chung-Ang University Gwangmyeong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2024

Primary Completion (Estimated)

January 22, 2025

Study Completion (Estimated)

March 22, 2025

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2311123132

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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