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Efficacy and Safety of Ciprofol Versus Propofol for Sedation in ICU Patients With Mechanical Ventilation: A Multi-Center, Double-Blind, Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Adults are sequentially admitted to ICU undergoing mechanical ventilation; Patients are expected to need 6-24 hours of sedation for the target RASS ranged from +1 to -2 after randomization;

• Aged ≥ 18 and ≤ 80 years old, with no gender requirement;

• The patients or their family members fully understood the objectives and significance of this study and voluntarily participated and signed informed consent forms.

Locations
Other Locations
China
Zhongda Hospital, Southeast University, No. 87, Dingjiaqiao Road, Gulou District, Nanjing, 210009, People's Republic of China.
RECRUITING
Nanjing
Contact Information
Primary
Fei Peng
afei0312@163.com
15950565786
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 366
Treatments
Experimental: Ciprofol
Active_comparator: Propofol
Related Therapeutic Areas
Sponsors
Collaborators: Hebei Medical University Fourth Hospital, Huai'an First People's Hospital, Xuzhou Medical University Hospital, First Affiliated Hospital of Suzhou Medical College, First Affiliated Hospital of Kunming Medical University, China-Japan Union Hospital, Jilin University, Suqian First Hospital, Taian City Central Hospital, Second Affiliated Hospital of Suzhou University, The first People's Hospital of Yancheng City, Xuzhou Central Hospital, Renmin Hospital of Wuhan University, Zhongnan Hospital, Jinan City People's Hospital, The First Affiliated Hospital of Air Force Medicial University, First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital), The First Affiliated Hospital of Nanchang University, Jiangxi Provincial People's Hopital, First Affiliated Hospital Xi'an Jiaotong University, The Ninth People's Hospital of Suzhou, First People's Hospital of Hangzhou, The First People's Hospital of Zunyi, First Affiliated Hospital, Sun Yat-Sen University, The First People's Hospital of Lianyungang, Sichuan Academy of Medical Sciences, Zhongnan University Xiangya Second Hospital, Anhui provincial chest hospital, Fifth Affiliated Hospital of Xinjiang Medical University, Henan Provincial People's Hospital, Jiangsu Subei People's Hospital, The Guangxi Zhuang Autonomous Region People's Hospital
Leads: Zhongda Hospital

This content was sourced from clinicaltrials.gov