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Not Yet Recruiting 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07740655). StuddyBuddy aggregates publicly available trial information.