Comparing Remimazolam and Midazolam for Sedation in Critically Ill Patients on Ventilators

Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam - A Parallel, Multicenter, Single-blind Randomized Controlled Trial

This study is testing if a new sedative called remimazolam can help critically ill patients on ventilators spend less time on the machine compared to the standard sedative midazolam.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 440 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Zhujiang Hospital (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05160987 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of remimazolam versus midazolam on the duration of mechanical ventilation in critically ill patients. It is a multicenter, single-blind, randomized controlled trial where patients will be assigned to receive either remimazolam or midazolam for sedation. The primary goal is to determine if remimazolam can reduce the time patients spend on mechanical ventilation compared to midazolam. Patients aged 18 to 80 who are mechanically ventilated within 48 hours of ICU admission and expected to stay in the ICU for over 72 hours will be enrolled.

Who should consider this trial

Good fit: Ideal candidates are critically ill patients aged 18 to 80 who are mechanically ventilated within the first 48 hours of ICU admission.

Not a fit: Patients with severe heart conditions, neurological injuries, or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved sedation management and reduced duration of mechanical ventilation for critically ill patients.

How similar studies have performed: Other studies have shown promising results with remimazolam in sedation, suggesting potential benefits, but this specific comparison with midazolam is novel.

Eligibility 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.
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.

Where this trial is running

Guangzhou, Guangdong

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

Study contacts

• Principal investigator: Zhanguo Liu, M.D.PhD — Department of Critical Care Medicine of Zhujiang Hospital
• Study coordinator: Jing Cai

Conditions: Sedation and Analgesia, Remimazolam, Midazolam, duration of mechanical ventilation, Sedation