NCT06507202

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Chung-Ang University Gwangmyeong Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laryngeal Disease
• Pharyngeal Diseases
• Oral Cavity Disease
• Nasal Disease

Interventions

Type	Name	Description
DRUG	Remimazolam	General anesthesia is induced and maintained by continuous infusion of remimazolam and remifentanil, and recovered with flumazenil.
DRUG	Propofol	General anesthesia is induced and maintained by continuous infusion of propofol and remifentanil.

Timeline

• Start date: 2024-01-22
• Primary completion: 2025-01-22
• Completion: 2025-03-22
• First posted: 2024-07-18
• Last updated: 2024-07-18

Locations

1 site across 1 country: South Korea