Comparing remimazolam versus propofol for sedation during endoscopy
Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration (SERENE)
This trial tests whether remimazolam works as well as propofol for sedating adults having planned endoscopic procedures.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07269808 on ClinicalTrials.gov |
What this trial studies
This is a pragmatic, randomized, controlled pilot trial at a single center comparing remimazolam with propofol for procedural sedation during endoscopy. Adults with ASA physical status I–III who are scheduled for an endoscopic procedure of under 45 minutes are randomly assigned to receive one of the two IV sedatives. The trial focuses on feasibility, clinical outcomes such as adequacy of sedation, recovery time, and adverse events, and it uses routine clinical monitoring and dosing protocols. Results will inform whether a larger pragmatic trial of sedation practices in the endoscopy setting is practical and warranted.
Who should consider this trial
Good fit: Adults aged 18 or older who are scheduled for a planned endoscopic procedure, have ASA physical status I–III, and whose procedure is expected to last less than 45 minutes are ideal candidates.
Not a fit: Patients who need tracheal intubation, expect procedures longer than 45 minutes, are pregnant or breastfeeding, have allergies to the study drugs, or cannot communicate in English are unlikely to benefit from joining this trial.
Why it matters
Potential benefit: If successful, the trial could identify a sedation option that provides effective sedation with faster recovery or fewer side effects for patients undergoing endoscopy.
How similar studies have performed: Previous procedural sedation trials of remimazolam have shown effective sedation with rapid recovery and a favorable hemodynamic profile compared with other agents, so the approach has supportive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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, in the opinion of the site investigator and/or their delegate, might interfere with study participation, collection, or interpretation of the study data
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Oluwaseun Johnson-Akeju, MD — Massachusetts General Hospital
- Study coordinator: Oluwaseun Johnson-Akeju, MD
- Email: oluwaseun.akeju@mgh.harvard.edu
- Phone: 617-726-3030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.