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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-79
SponsorJeju National University School of Medicine

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Contraindications to remimazolam.

History of allergy or hypersensitivity to benzodiazepines.

Inability to provide informed consent due to cognitive impairment.

Preexisting psychiatric disorders.

Trial design

Treatments tested in this trial

  • Remimazolam

Treatment groups

138 Participants
are divided into 2 treatment groups