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REMIMID-ICU: Remimazolam vs Midazolam for Deep Sedation in Hemodynamically Unstable, Mechanically Ventilated Adults
Sponsor: Yancheng First People's Hospital
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.
Official title: ClinicalTrials.Gov PRS Field-by-Field Checklist & Results Module Templates - REMIMID-ICU
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2025-10-01
Completion Date
2027-09-30
Last Updated
2025-09-04
Healthy Volunteers
No
Interventions
Remimazolam Besylate
Continuous IV infusion; start 0.10 mg/kg/h and titrate every 15-30 minutes in 0.025-0.05 mg/kg/h steps to target RASS -3 to -5 (allowable range -2 to -5 for clinical safety). Maximum typical rate 0.20 mg/kg/h; temporary higher rates permitted per protocol for breakthrough agitation.
Midazolam
Continuous IV infusion; start 0.04 mg/kg/h and titrate every 15-30 minutes in 0.01-0.03 mg/kg/h steps to target RASS -3 to -5 (allowable range -2 to -5). Maximum typical rate 0.20 mg/kg/h per protocol.