Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration
NCT ID: NCT07269808
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2025-12-01
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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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.
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
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.
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.
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned endoscopic procedure
* American Society of Anesthesiologists (ASA) Physical Status I to III
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Oluwaseun Johnson-Akeju, MD, MMSc
Chair, Department of Anesthesiology
Principal Investigators
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Oluwaseun Johnson-Akeju, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Central Contacts
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Other Identifiers
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2025P002893
Identifier Type: -
Identifier Source: org_study_id
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