Clinical trial NCT06538883: Sedation in ICU Patients With Mechanical Ventilation
Official title: Efficacy and Safety of Ciprofol Versus Propofol for Sedation in ICU Patients With Mechanical Ventilation: A Multi-Center, Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiration, Artificial
Hypnotics and Sedatives
Keywords: Sedation
Mechanical Ventilation
ICU
Ciprofol
Propofol
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Air Force Medicial University
name: First Affiliated Hospital, Sun Yat-Sen University
name: Zhongnan University Xiangya Second Hospital
name: Renmin Hospital of Wuhan University
name: First Affiliated Hospital of Suzhou Medical College
name: The First Affiliated Hospital of Nanchang University
name: The Third Bethune Hospital of Jilin University
name: Zhongnan Hospital
name: First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital)
name: First Affiliated Hospital of the Xi'an Jiaotong University
name: First Affiliated Hospital of Kunming Medical University
name: Sichuan Academy of Medical Sciences
name: Anhui provincial chest hospital
name: The Guangxi Zhuang Autonomous Region People's Hospital
name: Second Affiliated Hospital of Suzhou University
name: The Ninth People's Hospital of Suzhou
name: Fifth Affiliated Hospital of Xinjiang Medical University
name: Xuzhou Medical University Hospital
name: First People's Hospital of Hangzhou
name: Hebei Medical University Fourth Hospital
name: Huai'an First People's Hospital
name: Jinan City People's Hospital
name: The First People's Hospital of Lianyungang
name: Jiangsu Subei People's Hospital
name: Suqian First Hospital
name: Tai'an City Central Hospital
name: Xuzhou Central Hospital
name: The first People's Hospital of Yancheng City
name: The First People's Hospital of Zunyi
name: Jiangxi Provincial People's Hopital
name: Henan Provincial People's Hospital
First posted: 2024-08-06
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion criteria (patients who met all the following criteria):

1. 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;
2. Aged ≥ 18 and ≤ 80 years old, with no gender requirement;
3. The patients or their family members fully understood the objectives and significance of this study and voluntarily participated and signed informed consent forms.

Exclusion criteria (patients who met 1 of the following criteria were excluded):

1. Patients known to be allergic or contraindicated to ciprofol. 2. BMI\<18 kg/m2 or \>30 kg/m2. 3. Patients who had received sedation for more than 3 days in an ICU or in a general ward prior to being transferred to the ICU before signing an informed consent form.

4. Patients have the following medical history or evidence of any of the following conditions at screening, which may increase the sedation/anesthesia risk:

1. Cardiovascular system: New York Heart Association (NYHA) Class III and IV heart failure, Adams-stokes syndrome; patients who required vasopressor (equivalent norepinephrine ≥ 1μg/kg/min) to maintain a normal blood pressure.
2. Patients with hepatic and renal failure (liver function: refer to Child-Pugh grade C; renal function: eGFR ≤ 30 mL/(min·1.73 m2) \[eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) equation: eGFR = 175 × serum creatinine (SCr) - 1.234 × age - 0.179 × 0.79 (females)\]; patients undergoing dialysis.
3. Patients with grand mal epilepsy and convulsion; a Glasgow coma scale (GCS) ≤ 12 points.

5. Patients with an expected survival of ≤ 24 h. 6. Pregnant or lactating females. 7. Patients participated in other drug clinical trials before screening. 8. Other conditions that patients were judged by the investigator to be unsuitable for inclusion in the study.

Primary outcomes:
measure: The primary outcome is the rate of successful sedation without hypotension
timeFrame: within the first 30 minutes of administering the study drug
Secondary outcomes:
measure: the rate of within sedation target (RASS: +1 to -2) without hypotension in the first 1hour of administering the study drug;
timeFrame: within the first 1hour of administering the study drug
measure: 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;
timeFrame: within the first 1hour of administering the study drug
measure: Usage of study drugs
timeFrame: within the first 24hours of administering the study drug
measure: Duration of mechanical ventilation
timeFrame: 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
measure: Extubation time
timeFrame: from intubation (for patients intubated after ICU admission) or ICU admission (for patients admitted with intubation) to extubation
measure: Awakening time
timeFrame: 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
measure: Incidence of delirium
timeFrame: 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
measure: Length of ICU stay
timeFrame: the time from ICU admission to discharge from the ICU or death from any cause, whichever came first, assessed up to 28 days
measure: The 28-day mortality
timeFrame: from administation of study drug to 28 days
measure: Incidence of hypotension
timeFrame: from the time of signing informed consent to 2 hours after the end of study drug administration
measure: Incidence of bradycardia
timeFrame: from the time of signing informed consent to 2 hours after the end of study drug administration
Other outcomes:
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