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

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

Incidence of Emergence Agitation

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

Secondary outcomes

Time to Tracheal Extubation

Time frame: From anesthesia discontinuation to extubation in the operating room
Intraoperative Hemodynamic Stability

Time frame: During anesthesia
Incidence of Airway Complications During Emergence

Time frame: during anesthesia

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kyung Won Shin

CONTACT

[email protected]

02-2072-2469

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Dec 4, 2025
Registry last updated: Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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