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.
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.
Contraindications to remimazolam.
History of allergy or hypersensitivity to benzodiazepines.
Inability to provide informed consent due to cognitive impairment.
Preexisting psychiatric disorders.
Parallel
Remimazolam
DrugRemimazolam 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.
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.
Incidence of burst suppression
Burst suppression is defined as a suppression ratio greater than 0% lasting for at least 1 minute or occurring repeatedly between study drug administration and extubation.
Duration of burst suppression
Cumulative duration of suppression ratio greater than 0% measured using the SedLine monitor.
Lowest Patient State Index (PSI)
Lowest Patient State Index recorded after study drug administration.
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