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

NCT07155265 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-09-04

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

Midazolam

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 & Collaborators

  • Yancheng First People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-06-30
Completion
2027-09-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07155265 on ClinicalTrials.gov