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NCT07740655
Low-dose Versus Standard-dose Remimazolam for Prevention of Emergence Agitation After Nasal Surgery
Conditions: Emergence Agitation, General Anesthesia, Nasal Surgical Procedures
Sex: All
Ages: 18 Years – 79 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 138
Sponsor: Jeju National University School of Medicine
Location: Jeju National University Hospital Jeju City Jeju-do
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07740655). StuddyBuddy aggregates publicly available trial information.