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

NCT07265050 | Not Yet Recruiting

• 1 other identifier: 2507-174-1661
• Study Type: interventional
• Target: 204
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Emergence Agitation

Outcome Measures

Primary Outcomes (1)

• Incidence of Emergence Agitation

  From discontinuation of anesthesia to exit in the operating room

Secondary Outcomes (3)

• 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

Study Arms (2)

Remimazolam

EXPERIMENTAL

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.

Drug: Remimazolam with Flumazenil

Propofol

ACTIVE COMPARATOR

Participants receive general anesthesia induced and maintained with propofol.

Drug: Propofol

Interventions

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.

Remimazolam

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.

Propofol

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adults aged 19 years or older scheduled to undergo nasal surgery requiring general anesthesia

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Emergence Delirium

Interventions

remimazolam; Flumazenil; Propofol

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Kyung Won Shin

CONTACT

02-2072-2469; skwskw126@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-11