Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration (SERENE)
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Number of Patients Meeting Inclusion/Exclusion Criteria
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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, in the opinion of the site investigator and/or their delegate, might interfere with study participation, collection, or interpretation of the study data
Arms & Interventions
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.
Intervention: Remimazolam (Drug)
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.
Intervention: Propofol (Drug)
Outcomes
Primary Outcomes
Number of Patients Meeting Inclusion/Exclusion Criteria
Time Frame: From initiation of screening through end of study enrollment period.
Counts the number of patients screened who meet all prespecified inclusion and exclusion criteria for trial eligibility.
Number of Patients Consented
Time Frame: From initiation of recruitment through end of study enrollment period.
Total number of eligible patients who provide informed consent to participate in the study.
Number of Patients Receiving the Randomized Intervention Per Protocol
Time Frame: From randomization through completion of the endoscopic procedure.
Number of consented participants who are successfully randomized and receive their assigned sedation intervention according to the study protocol without major deviations.
Number of Completed Questionnaires
Time Frame: At the end of the procedure and at the immediate post-procedure assessment.
Total number of study-related questionnaires completed by participants at the designated assessment time points, used to evaluate feasibility and acceptability of study procedures.
Secondary Outcomes
No secondary outcomes reported
Investigators
Oluwaseun Johnson-Akeju, MD, MMSc
Chair, Department of Anesthesiology
Massachusetts General Hospital