Emergence Agitation
Conditions
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.
Interventions
DRUGRemimazolam 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.
DRUGPropofol
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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Adults aged 19 years or older scheduled to undergo nasal surgery requiring general anesthesia
Exclusion criteria
* 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 * Any condition judged by the investigator to make participation inappropriate (e.g., unstable medical status, severe comorbidities)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Emergence Agitation | From discontinuation of anesthesia to exit in the operating room |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Complications such as coughing, desaturation, and laryngospasm will be recorded based on direct observation by anesthesiologists. |
Contacts
Primary ContactKyung Won Shin
Outcome results
None listed