Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration

NCT07269808 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: 2025P002893
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Sedation; Endoscopy

Outcome Measures

Primary Outcomes (4)

• Number of Patients Meeting Inclusion/Exclusion Criteria

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

  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.

  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.

  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.

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

Other Outcomes (12)

• Incidence and Duration of Adverse Clinical Events

  From induction of sedation through end of the procedure

• Procedural Success

  From induction of sedation through end of the procedure

• Patient Satisfaction

  At the immediate post-procedure assessment

Study Arms (2)

Arm Title: Remimazolam Sedation

EXPERIMENTAL

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.

Drug: Remimazolam

Propofol Sedation

ACTIVE COMPARATOR

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.

Drug: Propofol

Interventions

Remimazolam DRUG

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

Also known as: Byfavo

Arm Title: Remimazolam Sedation

Propofol DRUG

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.

Also known as: Diprivan

Propofol Sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years of age or older
• Planned endoscopic procedure
• American Society of Anesthesiologists (ASA) Physical Status I to III

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Oluwaseun Johnson-Akeju, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Anesthesiology

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 8, 2025
• Study Start: March 3, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)