NCT05160987 Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam
| NCT ID | NCT05160987 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhujiang Hospital |
| Condition | Sedation and Analgesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2022-03-29 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 440 participants in total. It began in 2022-03-29 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Zhanguo Liu, M.D.PhD
PRINCIPAL INVESTIGATOR
Department of Critical Care Medicine of Zhujiang Hospital
Frequently Asked Questions
Who can join the NCT05160987 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Sedation and Analgesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05160987 currently recruiting?
Yes, NCT05160987 is actively recruiting participants. Contact the research team at caijing78@hotmail.com for enrollment information.
Where is the NCT05160987 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05160987 clinical trial?
NCT05160987 is sponsored by Zhujiang Hospital. The principal investigator is Zhanguo Liu, M.D.PhD at Department of Critical Care Medicine of Zhujiang Hospital. The trial plans to enroll 440 participants.