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Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration
Sponsor: Massachusetts General Hospital
Summary
This study is a pragmatic, randomized controlled pilot trial comparing remimazolam with propofol for endoscopic procedures, designed to assess the feasibility and clinical outcomes associated with implementing a pragmatic randomized trial of sedation practices in the endoscopy setting.
Official title: Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration (SERENE)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-03-03
Completion Date
2026-06-01
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
Remimazolam
Remimazolam will be administered at 0.20 mg/kg for procedural sedation. The maximum initial bolus is 15 mg, with additional 2.5 mg doses given as needed to maintain sedation. Intravenous fentanyl (25-100 mcg) may be used adjunctively per clinician judgement
Propofol
Propofol will be administered with an initial bolus of up to 1.5 mg/kg, followed by intermittent 10-40 mg boluses according to routine clinical practice. Intravenous fentanyl (25-100 mcg) may be used adjunctively per clinician judgement.
Locations (1)
Massachusetts General Hospital
Boston, Massachusetts, United States