Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparison of Emergence Agitation Between Remimazolam With Flumazenil and Propofol-based Total Intravenous Anesthesia in Patients Undergoing Nasal Surgery
Sponsor: Seoul National University Hospital
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.
Official title: Comparison of Emergence Agitation Between Remimazolam With Flumazenil and Propofol-based Total Intravenous Anesthesia in Patients Undergoing Nasal Surgery: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
204
Start Date
2026-01-01
Completion Date
2027-12-31
Last Updated
2025-12-04
Healthy Volunteers
No
Conditions
Interventions
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.
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.