Comparison of Emergence Agitation Between Remimazolam With Flumazenil and Propofol-based Total Intravenous Anesthesia in Patients Undergoing Nasal Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Remimazolam with Flumazenil

    Drug

    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

    Drug

    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.

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: RemimazolamExperimental treatment 1 intervention
Group B: PropofolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Emergence Agitation

Time frame
From discontinuation of anesthesia to exit in the operating room

Secondary outcomes

1

Time to Tracheal Extubation

Time frame
From anesthesia discontinuation to extubation in the operating room
2

Intraoperative Hemodynamic Stability

Time frame
During anesthesia
3

Incidence of Airway Complications During Emergence

Complications such as coughing, desaturation, and laryngospasm will be recorded based on direct observation by anesthesiologists.

Time frame
during anesthesia

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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