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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Emergence Agitation
• Intervention / Treatment: Drug: Remimazolam with Flumazenil; Drug: Propofol

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kyung Won Shin; Phone Number: 02-2072-2469; Email: skwskw126@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam; 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; 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.
Active Comparator: Propofol; Participants receive general anesthesia induced and maintained with propofol.	Drug: Propofol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Emergence Agitation	From discontinuation of anesthesia to exit in the operating room

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Tracheal Extubation		From anesthesia discontinuation to extubation in the operating room
Intraoperative Hemodynamic Stability		During anesthesia
Incidence of Airway Complications During Emergence	Complications such as coughing, desaturation, and laryngospasm will be recorded based on direct observation by anesthesiologists.	during anesthesia

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: November 23, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Benzazepines; Benzodiazepines; Benzodiazepinones; Propofol; Flumazenil; remimazolam
• Other Study ID Numbers: 2507-174-1661

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No