Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration
Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration (SERENE)
Massachusetts General Hospital
100 participants
Mar 3, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- Aged 18 years of age or older
- Planned endoscopic procedure
- American Society of Anesthesiologists (ASA) Physical Status I to III
Exclusion Criteria7
- 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, in the opinion of the site investigator and/or their delegate, might interfere with study participation, collection, or interpretation of the study data
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Interventions
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 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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07269808