Anesthesia, Endoscopy, Sedation
Conditions
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.
Interventions
DRUGRemimazolam
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
DRUGPropofol
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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Meeting Inclusion/Exclusion Criteria | 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 | 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 | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOROluwaseun Johnson-Akeju, MD
Massachusetts General Hospital
Outcome results
None listed