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

Yancheng First People's Hospital

Status and phase: Not yet enrolling; Phase 3

Conditions: Critical Illness; Mechanical Ventilation; Shock

Treatments: Drug: Remimazolam Besylate; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT07155265

YCSYY-【2025】-(J-050)

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

• Age ≥18 years.
• Invasive mechanical ventilation at randomization; anticipated continuous sedation ≥24 hours.
• Hemodynamic instability requiring vasopressor support despite adequate resuscitation: NEE ≥0.10 μg/kg/min for ≥1 hour within 6 hours prior to randomization, or equivalent.
• At least one sign of hypoperfusion (e.g., lactate >2 mmol/L, oliguria, mottled skin, or altered mentation) unless solely due to sedation.

Exclusion

• Known pregnancy; status epilepticus; severe hepatic failure (Child-Pugh C) or on ECMO; refractory hypoxemia requiring prone position at randomization; benzodiazepine hypersensitivity; need for continuous neuromuscular blockade >24h at baseline; moribund not expected to survive 24h; investigator judgement.

Sexes Eligible: All Accepts Healthy Volunteers: No Ages: 18 Years and older

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups

Arm A - Remimazolam

Experimental group

Description:

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.

Treatment:

Drug: Remimazolam Besylate

Arm B - Midazolam

Experimental group

Description:

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.

Treatment:

Drug: Midazolam