Remimazolam: Remimazolam will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.
Midazolam: Midazolam will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.
Study summary
In this parallel, multicenter, single-blind randomized controlled trial, mechanical ventilated patients will be randomly assigned to two groups. One receives remimazolam to achieve sedation goals, while the other receives Midazolam. The primary outcome is the effect of remimazolam on duration of mechanical ventilated of critical patients compared to midazolam.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Critical ill patients that are mechanically ventilated within the first 48h of admission to the ICU and who would remain in the ICU for over 72h were enrolled in this study.
2. Age 18-80 years.
3. Voluntary informed consent.
Exclusion Criteria:
1. Surgical treatment is performed within 24 hours.
2. Craniocerebral injury, post neurosurgery, non drug coma, mental illness or peripheral neuropathy.
3. Heart rates are less than 50 beats / min or severe atrioventricular block without pacemaker support.
4. The mean arterial pressure is less than 55 mmHg even though fluids and vasoactive drugs are administrated.
5. Patients who are known or suspected allergy to benzodiazepines, propofol, dexmedetomidine or opioids.
6. History of alcohol and drug abuse.
7. End stages of lung diseases, such as pulmonary fibrosis, lung damage, etc.
8. Pregnancy.
Primary outcome measure(s)
Duration of mechanical ventilation — From the date of enrollment until the date of successful ventilator withdrawal, assessed up to 28 days Weaning success is typically regarded as consecutive ventilator-free over 24h following liberation from a ventilator. The duration of mechanical ventilation is from the enrollment time to the weaning time.
The study and observation would be stopped due to difficult ventilator weaning, which features weaning failure repeatedly for 3 weeks.
Trial sites (1)
Facility
City
Region
Status
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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