Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Sedation and Analgesia

In brief

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.

Key facts

Study ID: NCT05160987
Run by: Zhujiang Hospital
People needed: 440
Starts: 2022-03-29
Expected to finish: 2027-12-31
Last updated by the study team: 2026-04-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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