Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration (SERENE)

Mass General Brigham

Status and phase: Not yet enrolling; Phase 3

Conditions: Sedation; Endoscopy; Anesthesia

Treatments: Drug: Remimazolam; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT07269808

2025P002893

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Arm Title: Remimazolam Sedation

Experimental group

Description:

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.

Treatment:

Drug: Remimazolam

Propofol Sedation

Active Comparator group

Description:

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.

Treatment:

Drug: Propofol