Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration (SERENE)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Aged 18 years of age or older
• Planned endoscopic procedure
• American Society of Anesthesiologists (ASA) Physical Status I to III
Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Oluwaseun Johnson-Akeju, MD
oluwaseun.akeju@mgh.harvard.edu
617-726-3030
Backup
Ariel Mueller, MA
almueller@mgh.harvard.edu
6177269252
Time Frame
Start Date: 2026-03-03
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 100
Treatments
Experimental: Arm Title: Remimazolam Sedation
Participants randomized to this arm will receive remimazolam 0.20 mg/kg for procedural sedation. The maximum initial bolus will be 15 mg, with additional doses administered in 2.5 mg increments as needed to maintain adequate sedation. Intravenous fentanyl (25-100 mcg) may be administered as an adjunct per clinician judgement. This dosing strategy reflects the institution's standard-of-care approach to remimazolam-based sedation.
Active_comparator: Propofol Sedation
Participants randomized to this arm will receive propofol up to 1.5 mg/kg as the initial bolus, followed by intermittent boluses of 10-40 mg according to routine clinical practice. Intravenous fentanyl (25-100 mcg) may be administered as an adjunct per clinician judgement. This regimen reflects the institution's standard-of-care approach to propofol-based sedation.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital