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

Phase 4

Recruiting

• Conditions: Laryngeal Disease; Oral Cavity Disease; Pharyngeal Diseases; Nasal Disease
• Interventions: Drug: Remimazolam; Drug: Propofol

• Registration Number: NCT06507202
• Lead Sponsor: Chung-Ang University Gwangmyeong Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-01-18
• Study Start: 2024-01-22
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Study First Posted: 2024-07-18
• Last Update Posted: 2024-07-18
• Primary Completion: 2025-01-22
• Study Completion: 2025-03-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam group	Remimazolam	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.
Propofol group	Propofol	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.

Primary Outcome Measures

Name	Time	Method
Fit-for-discharge time	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ChungAng University Gwangmyeong Hospital; 🇰🇷 Gyeonggi-do, Gwangmyeon-si, Korea, Republic of