Clinical Trial

Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation

Recruiting Phase 4
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Summary
A multi-center, prospective, randomized, double-blind, active-controlled, no-inferiority clinical trial conducted across 5 tertiary medical centers in China. The objective of this RCT is to evaluate the sedative efficacy and safety profile of remimazolam besylate compared with dexmedetomidine in patients requiring mechanical ventilation following non-cardiac surgery. The study hypothesized that remimazolam besylate is non-inferior to dexmedetomidine regarding the primary efficacy outcome.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-06-17
notable Primary completion pushed: 2026-04-20 -> 2026-05-30 2026-06-17
Trial Details
NCT Number NCT06575530
Lead Sponsor Beijing Shijitan Hospital, Capital Medical University
Conditions Effect of Drug, Adverse Drug Event, Mechanical Ventilation Complication, Critical Illness, Surgery, Sedation
Enrollment 306 participants
Start Date 2025-01-20
Primary Completion 2026-05-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-16