Critical Illness; Mechanical Ventilation; Shock
Conditions
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.
Interventions
DRUGRemimazolam 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.
DRUGMidazolam
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.
Sponsors
Yancheng First People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time within target sedation without rescue | 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. |
Contacts
Primary ContactLiangliang Zhou
Outcome results
None listed