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Low-dose Versus Standard-dose Remimazolam for Prevention of Emergence Agitation After Nasal Surgery
Sponsor: Jeju National University School of Medicine
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.
Official title: Low-dose Versus Standard-dose Remimazolam for Prevention of Emergence Agitation After Nasal Surgery Under Sevoflurane Anesthesia: A Randomized Double-blind Non-inferiority Trial
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
138
Start Date
2026-07-24
Completion Date
2027-07-31
Last Updated
2026-07-31
Healthy Volunteers
No
Interventions
Remimazolam
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.
Locations (1)
Jeju National University Hospital
Jeju City, Jeju-do, South Korea