Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration (SERENE)
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Aged 18 years of age or older * Planned endoscopic procedure * American Society of Anesthesiologists (ASA) Physical Status I to III Exclusion Criteria: * Planned tracheal intubation * Procedure length anticipated to exceed 45 minutes * Previously participated in the trial * Pregnant (defined as a positive test using pre-procedural clinical testing performed as part of their routine care) or breastfeeding * Allergy or hypersensitivity to one of the study medications * Blind, deaf, or unable to communicate in English * Co-enrollment in other interventional studies that,…
Interventions
- DrugRemimazolam
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
- DrugPropofol
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.
Location
- Massachusetts General HospitalBoston, Massachusetts