Actively Recruiting
Effect of Remimazolam With Protocolized Sedation on Critically Ill Mechanical Ventilated Patients Compared With Midazolam A Parallel, Multicenter, Single-blind Randomized Controlled Trial
Led by Zhujiang Hospital · Updated on 2026-04-17
440
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
Z
Zhujiang Hospital
Lead Sponsor
I
Integrated traditional Chinese and Western Medicine Hospital of Southern Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of remimazolam compared with midazolam on sedation and mechanical ventilation duration in critically ill patients who require mechanical ventilation. This randomized controlled trial includes patients aged 18 to 80 years who are mechanically ventilated within 48 hours of ICU admission and expected to remain in ICU for more than 72 hours. The study aims to determine if remimazolam can reduce the duration of mechanical ventilation compared to midazolam in these severe patients. Participants are randomly assigned to one of two groups. One group receives remimazolam starting with an intravenous bolus dose of 0.1 to 0.3 mg/kg over one minute, followed by a maintenance infusion of 0.1 to 0.25 mg/kg/hour, with doses adjusted according to sedation levels measured by the Richmond Agitation Sedation Scale (RASS). The other group receives midazolam with an initial bolus dose of 0.01 to 0.05 mg/kg, followed by a maintenance dose of 0.02 to 0.1 mg/kg/hour, also adjusted based on RASS scores. Nonbenzodiazepine sedatives may be added if sedation goals are not met. Daily spontaneous breathing tests are performed when patients are stable to assess readiness for weaning from mechanical ventilation. Throughout the study, researchers monitor sedation success, duration of mechanical ventilation, duration of intubation, length of ICU and hospital stay, and safety outcomes such as hypotension, delirium, extubation events, and thrombus occurrence. The primary outcome is the time from enrollment to successful ventilator withdrawal, observed up to 28 days. Secondary outcomes include sedation goal completion, need for additional sedatives, anterograde amnesia, 28-day mortality, and cost assessments. Safety is closely tracked, and the total study duration per participant is up to 28 days or until successful weaning from ventilation.
CONDITIONS
Brief Title
Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Critical ill patients mechanically ventilated within 48 hours of ICU admission and expected to stay in ICU over 72 hours
- Age between 18 and 80 years
- Voluntary informed consent obtained
You will not qualify if you...
- Surgery performed within 24 hours
- Craniocerebral injury, post neurosurgery, non-drug coma, mental illness, or peripheral neuropathy
- Heart rate less than 50 beats per minute or severe atrioventricular block without pacemaker
- Mean arterial pressure less than 55 mmHg despite fluids and vasoactive drugs
- Known or suspected allergy to benzodiazepines, propofol, dexmedetomidine, or opioids
- History of alcohol or drug abuse
- End-stage lung diseases such as pulmonary fibrosis or lung damage
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days or until successful weaning from mechanical ventilation
Participants receive sedation with either remimazolam or midazolam while mechanically ventilated in the ICU. Dosages are adjusted according to sedation scales. Daily spontaneous breathing tests are conducted to assess readiness for weaning from ventilation.
Daily assessments during sedation and ventilation
Duration - Up to 28 days from enrollment
Participants are monitored after stopping sedation and ventilator weaning to assess recovery and any adverse events.
Visits as needed until study completion
Trial Site Locations
Total: 1 location
1
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
Guangzhou, Guangdong, China, 510282
Actively Recruiting
Research Team
J
Jing Cai
Z
Zhanguo Liu, M.D.PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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