Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration

Phase 3Not Yet RecruitingNCT07269808

Massachusetts General Hospital100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

100

Conditions

Anesthesia Sedation Endoscopy

Interventions

RemimazolamDRUG

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

PropofolDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Patients Meeting Inclusion/Exclusion Criteria

Counts the number of patients screened who meet all prespecified inclusion and exclusion criteria for trial eligibility.

Time frame: From initiation of screening through end of study enrollment period.

Number of Patients Consented

Total number of eligible patients who provide informed consent to participate in the study.

Time frame: From initiation of recruitment through end of study enrollment period.

Number of Patients Receiving the Randomized Intervention Per Protocol

Number of consented participants who are successfully randomized and receive their assigned sedation intervention according to the study protocol without major deviations.

Time frame: From randomization through completion of the endoscopic procedure.

Number of Completed Questionnaires

Total number of study-related questionnaires completed by participants at the designated assessment time points, used to evaluate feasibility and acceptability of study procedures.

Time frame: At the end of the procedure and at the immediate post-procedure assessment.

Central Contacts

Oluwaseun Johnson-Akeju, MD

CONTACT

617-726-3030 oluwaseun.akeju@mgh.harvard.edu

Ariel Mueller, MA

CONTACT

6177269252 almueller@mgh.harvard.edu

Data from ClinicalTrials.gov

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