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Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration

NCT07269808 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Oluwaseun Johnson-Akeju, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-03
Primary Completion
2026-07-01
Completion
2026-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07269808 on ClinicalTrials.gov