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

Phase 3Not Yet RecruitingNCT07155265

Yancheng First People's Hospital180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

180

Conditions

Critical Illness; Mechanical Ventilation; Shock

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 0-48 hours post-randomization