Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam
Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam - A Parallel, Multicenter, Single-blind Randomized Controlled Trial
Zhujiang Hospital
440 participants
Mar 29, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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.
- Age 18-80 years.
- Voluntary informed consent.
Exclusion Criteria8
- Surgical treatment is performed within 24 hours.
- Craniocerebral injury, post neurosurgery, non drug coma, mental illness or peripheral neuropathy.
- Heart rates are less than 50 beats / min or severe atrioventricular block without pacemaker support.
- The mean arterial pressure is less than 55 mmHg even though fluids and vasoactive drugs are administrated.
- Patients who are known or suspected allergy to benzodiazepines, propofol, dexmedetomidine or opioids.
- History of alcohol and drug abuse.
- End stages of lung diseases, such as pulmonary fibrosis, lung damage, etc.
- Pregnancy.
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Interventions
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 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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05160987