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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Critical Illness; Mechanical Ventilation; Shock Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

Percentage of time within target sedation without rescue

Time frame: 0-48 hours post-randomization

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Liangliang Zhou

CONTACT

[email protected]

18260087965

Sponsors and collaborators

Lead sponsor

Yancheng First People's Hospital

Other

Registry information

Official study title

ClinicalTrials.Gov PRS Field-by-Field Checklist & Results Module Templates - REMIMID-ICU

Acronym: REMIMID-ICU

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Sep 4, 2025
Registry last updated: Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting