drugset / Trial / NCT07155265

REMIMID-ICU: Remimazolam vs Midazolam for Deep Sedation in Hemodynamically Unstable, Mechanically Ventilated Adults

NCT07155265

Phase 3 Not yet recruiting 180 enrolled Yancheng First People's Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This trial evaluates whether remimazolam provides superior sedation quality compared with midazolam in adults receiving invasive mechanical ventilation with ongoing vasopressor support. The primary outcome is the percentage of time within target sedation (RASS -3 to -5) without rescue sedative during the first 48 hours after randomization. Key secondary outcomes include vasopressor exposure (NEE AUC 0-48h), time to awakening, delirium incidence, ventilator-free days, and 28-day mortality.

Timeline

Start
2025-10-01
Primary completion
2027-06-30
Completion
2027-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Midazolam Small molecule 0.2 mg/kg Intravenous
Subject Remimazolam Small molecule 0.2 mg/kg Intravenous

Indications