NCT07269808

Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-03-03
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-12-08
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study