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Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration

Study acronym: SERENE
StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Primary and study completion dates changed from estimate of Jul 1, 2026 to Jun 27, 2026v4 Show 1 more changeShow less
    • Primary and study completion dates changed from estimate of Jul 1, 2026 to Jun 27, 2026
  2. Trial status changed: Recruiting → Active, Not Recruiting Primary and study completion pushed from Jun 1, 2026 to Jul 1, 2026 · Site details revisedv3 Show 2 more changesShow less
    • Primary and study completion pushed from Jun 1, 2026 to Jul 1, 2026
    • Site details revised
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 1, 2025 to Mar 3, 2026 · Study sites: 0 to 1v2 Show 2 more changesShow less
    • Start date changed from estimate of Dec 1, 2025 to Mar 3, 2026
    • Study sites: 0 to 1
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07269808
Lead Sponsor Massachusetts General Hospital
Conditions Anesthesia, Sedation, Endoscopy
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov