Actively Recruiting
Sedation in ICU Patients With Mechanical Ventilation
Led by Zhongda Hospital · Updated on 2026-04-16
366
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
Z
Zhongda Hospital
Lead Sponsor
T
The First Affiliated Hospital of Air Force Medicial University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Sedatives are the mostly common prescription for patients with mechanical ventilation due to the disease or therapies. Ciprofol is a new intravenous anesthetic agent transformed from propofol, and has a similar sedative effect of propofol in previous study. Whether ciprofol is safe and effective similar with propofol for sedation in ICU patients with mechanical ventilation? Therefor, a multi-center, double-blind, randomized control trial was conducted with a noninferiority design, to compared the rate of successful sedation without hypotension of sedation by ciprofol or propofol in ICU patients with mechanical ventilation. A Multi-Center, Double-Blind, Randomized Controlled Trial will be launched to evaluate the efficacy and safety of ciprofol versus propofol for sedation in ICU patients with mechanical ventilation.
CONDITIONS
Official Title
Sedation in ICU Patients With Mechanical Ventilation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults admitted to ICU undergoing mechanical ventilation needing sedation for 6 to 24 hours targeting RASS +1 to -2 after randomization
- Age between 18 and 80 years, any gender
- Patients or family members who understand the study and voluntarily sign informed consent forms
You will not qualify if you...
- Known allergy or contraindication to ciprofol
- Body mass index (BMI) less than 18 kg/m2 or greater than 30 kg/m2
- Received sedation for more than 3 days in ICU or general ward before ICU transfer and consent
- Medical history or conditions increasing sedation risk including NYHA Class III/IV heart failure, Adams-Stokes syndrome, high-dose vasopressor need
- Hepatic failure (Child-Pugh grade C), renal failure (eGFR ≤ 30 mL/min/1.73 m2), or dialysis
- Grand mal epilepsy, convulsions, or Glasgow coma scale ≤ 12
- Expected survival ≤ 24 hours
- Pregnant or lactating females
- Participation in other drug clinical trials before screening
- Any other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongda Hospital, Southeast University, No. 87, Dingjiaqiao Road, Gulou District, Nanjing, 210009, People's Republic of China.
Nanjing, Jiangsu, China, 210009
Actively Recruiting
Research Team
F
Fei Peng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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