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

NCT07155265 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: YCSYY-【2025】-(J-050)
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Critical Illness; Mechanical Ventilation; Shock

Outcome Measures

Primary Outcomes (1)

• Percentage of time within target sedation without rescue

  Proportion (%) of all valid RASS assessments that are within -3 to -5 with no rescue sedative in the prior 60 minutes, during 0-48h after randomization.

  0-48 hours post-randomization

Study Arms (2)

Arm A - Remimazolam

EXPERIMENTAL

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: Remimazolam Besylate

Arm B - Midazolam

EXPERIMENTAL

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.

Drug: Midazolam

Interventions

Remimazolam Besylate DRUG

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.

Arm A - Remimazolam

Midazolam DRUG

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.

Arm B - Midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yancheng First People's Hospital: lead

MeSH Terms

Conditions

Critical Illness; Shock

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Liangliang Zhou

CONTACT

18260087965; 18812441561@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: graduate student

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share