Clinical trial Recruiting at 1 site Interventional Ages 18 to 80

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

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

Run by Zhujiang Hospital · NCT05160987 · Data updated 2026-11-12

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.

More Sedation and Analgesia trials

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment440 (estimated)
SponsorZhujiang Hospital
Academic / other
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedMarch 29, 2022
Main results expectedNovember 30, 2027
Study endsDecember 31, 2027
Registry record updatedApril 17, 2026
Trial IDNCT05160987 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably not a fit

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

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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
  • Email: caijing78@hotmail.com
  • Phone: +86-2062782927

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.