Sedation in ICU Patients With Mechanical Ventilation
NCT Number: NCT06538883
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Respiration, Artificial|Hypnotics and Sedatives
Interventions: DRUG: Sedation with Ciprofol|DRUG: Sedation with Propofol
Sponsor: Zhongda Hospital
Collaborators: Xijing Hospital, Air Force Medical University|First Affiliated Hospital, Sun Yat-Sen University|Zhongnan University Xiangya Second Hospital|Renmin Hospital of Wuhan University|First Affiliated Hospital of Suzhou Medical College|The First Affiliated Hospital of Nanchang University|The Third Bethune Hospital of Jilin University|Zhongnan Hospital of Wuhan University|First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital)|First Affiliated Hospital of the Xi'an Jiaotong University|First Affiliated Hospital of Kunming Medical University|Sichuan Academy of Medical Sciences|Anhui provincial chest hospital|The Guangxi Zhuang Autonomous Region People's Hospital|Second Affiliated Hospital of Suzhou University|The Ninth People's Hospital of Suzhou|Fifth Affiliated Hospital of Xinjiang Medical University|Xuzhou Medical University Hospital|First People's Hospital of Hangzhou|The Fourth Hospital of Hebei Medical University|Huai'an First People's Hospital|Jinan City People's Hospital|The First People's Hospital of Lianyungang|Jiangsu Subei People's Hospital|Suqian First People's Hospital|Tai'an City Central Hospital|Xuzhou Central Hospital|The first People's Hospital of Yancheng City|The First People's Hospital of Zunyi|Jiangxi Provincial People's Hopital|Henan Provincial People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 366
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-07-30

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.

Primary Outcome Measures: The primary outcome is the rate of successful sedation without hypotension, The primary outcome is the rate of successful sedation without hypotension, which have to meet the following three criteria simultaneously: 1) Sedation within the RASS target (+1 to -2); 2) No rescue therapy is used; 3) No hypotension occurs, within the first 30 minutes of administering the study drug., within the first 30 minutes of administering the study drug
Secondary Outcome Measures: the rate of within sedation target (RASS: +1 to -2) without hypotension in the first 1hour of administering the study drug;, within the first 1hour of administering the study drug|the rate of within sedation target (RASS: +1 to -2) without circulatory inhibition (defined as either hypotension or bradycardia) in the first 1hour of administering the study drug;, within the first 1hour of administering the study drug|Usage of study drugs, the total additional dose will be recorded;, within the first 24hours of administering the study drug|Duration of mechanical ventilation, Duration of mechanical ventilation: defined as the time from intubation (for patients intubated after ICU admission) or ICU admission (for patients admitted with intubation) to extubation;, from intubation (for patients intubated after ICU admission) or ICU admission (for patients admitted with intubation) until the date of first estubation or date of death from any cause, whichever came first, assessed up to 28 days|Extubation time, time from stopping the study drug to extubation; not applicable for patients who withdraw early or do not plan to extubate after stopping the drug;, from intubation (for patients intubated after ICU admission) or ICU admission (for patients admitted with intubation) to extubation|Awakening time, defined as the time from stopping the study drug to awakening from sedation (RASS ≥ 0). If RASS is ≥ 0 at the time of stopping the drug, the awakening time is recorded as 0;, from stopping the study drug until the time of awakening from sedation (RASS ≥ 0) or death from any cause, whichever came first, assessed up to 28 days|Incidence of delirium, Incidence of delirium, which is assessed using the CAM-ICU;, from administation of study drug until the time of awakening from sedation (RASS ≥ 0) or death from any cause, whichever came first, assessed up to 28 days|Length of ICU stay, defined as the time from ICU admission to discharge from the ICU;, the time from ICU admission to discharge from the ICU or death from any cause, whichever came first, assessed up to 28 days|The 28-day mortality, all caused mortality within 28 days., from administation of study drug to 28 days|Incidence of hypotension, Hypotension was defined as SBP \< 90 mmHg, or DBP \< 60 mmHg, or MAP \< 70 mmHg, or a drop of more than 30% from baseline, more than 2 minutes, or as determined by the investigator; and the use of vasopressor medications will be recorded;, from the time of signing informed consent to 2 hours after the end of study drug administration|Incidence of bradycardia, HR \< 40 bpm or a drop of more than 30% from baseline; the use of medications for bradycardia intervention, from the time of signing informed consent to 2 hours after the end of study drug administration