NCT07265050

Comparison of Emergence Agitation Between Remimazolam With Flumazenil and Propofol-based Total Intravenous Anesthesia in Patients Undergoing Nasal Surgery

Comparison of Emergence Agitation Between Remimazolam With Flumazenil and Propofol-based Total Intravenous Anesthesia in Patients Undergoing Nasal Surgery: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Participants will be randomly assigned to receive general anesthesia with either remimazolaml-based total intravenous anesthesia reversed with flumazenil or propofol-based total intravenous anesthesia. The primary outcome is the incidence of emergence agitation evaluated at the time of awakening after surgery. Additional outcomes include time to extubation, hemodynamic stability, airway complications such as coughing or laryngospasm, and postoperative recovery profiles including pain, nausea, vomiting, and sedation in the post-anesthesia care unit. This study aims to determine whether remimazolam with flumazenil provides smoother emergence compared with propofol in patients undergoing nasal surgery.

Conditions

• Emergence Agitation

Interventions

Type	Name	Description
DRUG	Remimazolam with Flumazenil	General anesthesia is induced and maintained with remimazolam (initial infusion approximately 6 mg/kg/hr for induction, then 1-2 mg/kg/hr for maintenance), along with remifentanil for analgesia. At the end of surgery, flumazenil is administered to reverse the sedative effect, starting with 0.2 mg IV, followed by 0.1 mg incremental doses every 1 minute as needed, up to a total dose of 1.0 mg.
DRUG	Propofol	General anesthesia is induced and maintained with propofol using target-controlled infusion (effect-site concentration up to 4.0 μg/mL), along with remifentanil for analgesia.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-12-04
• Last updated: 2025-12-04