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SERENE: Sedation During Endoscopy Using Remimazolam
NCT07269808Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2026
- Primary completion
- Jun 2026
- Countries
- 1
- Sponsor
- Massachusetts General Hospital
- Modality
- Small Molecules
- Drugs
- remimazolam
- Conditions
- Procedural sedation (PS)
01
Overview
Phase 3, randomised trial of remimazolam in Procedural sedation (PS) (2 arms), sponsored by Massachusetts General Hospital. Primary endpoints: Number of Patients Meeting Inclusion/Exclusion Criteria, Number of Patients Consented and 2 more. Started Mar 2026; status: completed.
02
Design
2 arms- Study design
- Randomized
Remimazolam Sedation
Remimazolam 0.20 mg/kg (max initial 15 mg), additional 2.5 mg doses as needed. Optional fentanyl 25-100 mcg.
Propofol Sedation
Propofol up to 1.5 mg/kg initial bolus, intermittent 10-40 mg boluses. Optional fentanyl 25-100 mcg.
03
Who it enrols
Adults undergoing planned endoscopic procedures with ASA Physical Status I to III, excluding those with planned tracheal intubation, procedure length >45 mins, or pregnant/breastfeeding.
04
Endpoints
Primary
Number of Patients Meeting Inclusion/Exclusion Criteria
Number of Patients Consented
Number of Patients Receiving the Randomized Intervention Per Protocol
Number of Completed Questionnaires
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