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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhujiang Hospital
• Collaborators: Bao'an District Central Hospital of Shenzhen; First Affiliated Hospital of Shantou University Medical College; Guangdong Province Traditional Medical hospital; Huizhou Third People's Hospital; Integrated traditional Chinese and Western Medicine Hospital of Southern Medical University; Shanwei People's Hospital; Shenzhen Hospital of Southern Medical University; Shenzhen University General Hospital; The Affiliated Hospital of Guangdong Medical College; The Fourth People's Hospital of Foshan; The Second People's Hospital of Foshan; The Third Affiliated Hospital of Guangzhou Medical University; Yunfu People's Hospital; Zhongshan Hospital Of Traditional Chinese Medicine
• Treatments: Midazolam

Criteria

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 or planned during ICU treatment.

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.