drugset / Trial / NCT07265050
Comparison of Emergence Agitation Between Remimazolam With Flumazenil and Propofol-based Total Intravenous Anesthesia in Patients Undergoing Nasal Surgery
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2026-01-01
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Flumazenil | Small molecule | 1 mg | Intravenous |
| Comparator | Propofol | Small molecule | 4 ug/ml | Intravenous |
| Subject | Remimazolam | Small molecule | 1 mg/kg | Intravenous |
| Subject | Remimazolam | Small molecule | 2 mg/kg | Intravenous |
| Comparator | Remifentanil | Small molecule | — | — |
Indications
No indication recorded.