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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

September 30, 2027

Conditions
Critical Illness; Mechanical Ventilation; Shock
Interventions
DRUG

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.

DRUG

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.

All Listed Sponsors
lead

Yancheng First People's Hospital

OTHER