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drugset / Trial / NCT06575530

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

NCT06575530 ↗

Phase 4 Recruiting 306 enrolled Beijing Shijitan Hospital, Capital Medical University
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-01-20
Primary completion
2026-05-30
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 0.2 ug/kg Intravenous
Comparator Dexmedetomidine Other / unclassified 0.7 ug/kg Intravenous
Subject Remimazolam Small molecule 0.1 mg/kg Intravenous
Subject Remimazolam Small molecule 1 mg/kg Intravenous

Indications

No indication recorded.