Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm Title: Remimazolam Sedation 		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
    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
    Other names:
    • Byfavo
Active Comparator
Propofol Sedation 		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
    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.
    Other names:
    • Diprivan

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02214
Contact:
Oluwaseun Johnson-Akeju, MD
617-726-3030
oluwaseun.akeju@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Oluwaseun Johnson-Akeju, MD
617-726-3030
oluwaseun.akeju@mgh.harvard.edu