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RECRUITING
NCT07269808
PHASE3

Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-03-03

Completion Date

2026-06-01

Last Updated

2026-03-05

Healthy Volunteers

No

Interventions

DRUG

Remimazolam

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

DRUG

Propofol

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.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States