Low-dose Versus Standard-dose Remimazolam for Prevention of Emergence Agitation After Nasal Surgery

NCT07740655 | Not Yet Recruiting Phase 4

• 1 other identifier: JEJUNUH 2026-06-005-001
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

Emergence agitation (EA) is a common complication during recovery from sevoflurane anesthesia, particularly after nasal surgery. Although remimazolam 0.1 mg/kg has been shown to reduce the incidence of EA, this dose may produce excessive sedation and increase the risk of intraoperative burst suppression. This randomized, double-blind, non-inferiority trial will compare low-dose remimazolam (0.03 mg/kg) with the standard dose (0.1 mg/kg) administered at the end of surgery in adult patients undergoing nasal surgery under sevoflurane anesthesia. The primary objective is to determine whether low-dose remimazolam is non-inferior to the standard dose in preventing emergence agitation. Secondary outcomes include burst suppression, recovery profiles, and safety outcomes.

Conditions

Emergence Agitation; General Anesthesia; Nasal Surgical Procedures

Keywords

Remimazolam; Emergence Agitation Sevoflurane; Nasal Surgery; Non-inferiority Trial

Outcome Measures

Primary Outcomes (1)

• Incidence of emergence agitation

  The incidence of emergence agitation within 15 minutes after extubation, defined as a Riker Sedation-Agitation Scale (SAS) score of 5 or greater.

  Within 15 minutes after extubation

Secondary Outcomes (3)

• Incidence of burst suppression

  From study drug administration until extubation(up to 30 minutes)

• Duration of burst suppression

  From study drug administration until extubation(up to 30 minutes)

• Lowest Patient State Index (PSI)

  From study drug administration until extubation(up to 30 minutes)

Study Arms (2)

Standard-dose Remimazolam

EXPERIMENTAL

Participants will receive remimazolam 0.1 mg/kg intravenously immediately after discontinuation of sevoflurane at the end of nasal surgery under general anesthesia.

Drug: Remimazolam

Low-dose Remimazolam

EXPERIMENTAL

Participants will receive remimazolam 0.03 mg/kg intravenously immediately after discontinuation of sevoflurane at the end of nasal surgery under general anesthesia.

Drug: Remimazolam

Interventions

Remimazolam DRUG

Remimazolam will be administered intravenously immediately after discontinuation of sevoflurane at the end of surgery. Participants will receive either 0.03 mg/kg or 0.1 mg/kg according to randomized treatment allocation.

Low-dose Remimazolam; Standard-dose Remimazolam

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 79 years.
• Scheduled to undergo elective nasal surgery under sevoflurane-based general anesthesia at Jeju National University Hospital.
• Able to provide written informed consent.

You may not qualify if:

• Contraindications to remimazolam.
• History of allergy or hypersensitivity to benzodiazepines.
• Inability to provide informed consent due to cognitive impairment.
• Preexisting psychiatric disorders.
• History of alcohol or substance abuse.
• Inability to assess the Riker Sedation-Agitation Scale (SAS).
• Body mass index (BMI) \> 40 kg/m².

Sponsors & Collaborators

• Jeju National University School of Medicine: lead

Study Sites (1)

Jeju National University Hospital

Jeju City, Jeju-do, South Korea

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

remimazolam

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

Central Study Contacts

Seung Eun Song, MD

CONTACT

+82-64-717-2031; ansongse@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesiology

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 31, 2026
• Study Start: July 24, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)