Comparison of Emergence Agitation Between Remimazolam With Flumazenil and Propofol-based Total Intravenous Anesthesia in Patients Undergoing Nasal Surgery: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 204
- Primary Endpoint
- Incidence of Emergence Agitation
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Remimazolam
Participants receive general anesthesia induced and maintained with remimazolam-based total intravenous anesthesia. At the end of surgery, flumazenil (0.2-1.0 mg) is administered to reverse the sedative effect.
Intervention: Remimazolam with Flumazenil (Drug)
Propofol
Participants receive general anesthesia induced and maintained with propofol.
Intervention: Propofol (Drug)
Outcomes
Primary Outcomes
Incidence of Emergence Agitation
Time Frame: From discontinuation of anesthesia to exit in the operating room
Secondary Outcomes
- Time to Tracheal Extubation(From anesthesia discontinuation to extubation in the operating room)
- Intraoperative Hemodynamic Stability(During anesthesia)
- Incidence of Airway Complications During Emergence(during anesthesia)