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

Seoul National University

Status: Not yet enrolling

Conditions: Emergence Agitation

Treatments: Drug: Remimazolam with Flumazenil; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT07265050

2507-174-1661

Details and patient eligibility

About

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.

Enrollment: 204 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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204 participants in 2 patient groups

Remimazolam

Experimental group

Description:

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.

Treatment:

Drug: Remimazolam with Flumazenil

Propofol

Active Comparator group

Description:

Participants receive general anesthesia induced and maintained with propofol.

Treatment:

Drug: Propofol