About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Declines or is unable to provide informed consent
Body mass index (BMI) ≥ 30 kg/m²
Pre-existing neurological or cognitive impairment
Known contraindication or allergy to remimazolam, propofol, or flumazenil
Trial design
Parallel
Treatments tested in this trial
Remimazolam with Flumazenil
DrugGeneral 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
DrugGeneral 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.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Emergence Agitation
Secondary outcomes
Time to Tracheal Extubation
Intraoperative Hemodynamic Stability
Incidence of Airway Complications During Emergence
Complications such as coughing, desaturation, and laryngospasm will be recorded based on direct observation by anesthesiologists.
Locations
Sponsors and contacts
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