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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhujiang Hospital

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Remimazolam
  • Midazolam

Treatment groups

440 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Zhujiang Hospital

Lead sponsor

Integrated traditional Chinese and Western Medicine Hospital of Southern Medical University

Collaborator

First Affiliated Hospital of Shantou University Medical College

Collaborator

Affiliated Hospital of Guangdong Medical University

Collaborator

Yunfu People's Hospital

Collaborator

Zhongshan Hospital Of Traditional Chinese Medicine

Collaborator

Guangdong Province Traditional Medical hospital

Collaborator

The Third Affiliated Hospital of Guangzhou Medical University

Collaborator