Sedation in ICU Patients With Mechanical Ventilation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sedation; Mechanical Ventilation
• Intervention / Treatment: Drug: Sedation with Propofol; Drug: Ciprofol

• Study Type: Interventional
• Enrollment (Estimated): 366
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fei Peng; Phone Number: 15950565786; Email: afei0312@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital, Southeast University, No. 87, Dingjiaqiao Road, Gulou District, Nanjing, 210009, People's Republic of China.
      • Contact: Peng Dr, PhD. MD.; Phone Number: 025-83262553; Email: afei0312@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol	Drug: Sedation with Propofol; During the drug administration period, propofol were IV infused at loading doses of 0.5 mg/kg, respectively, over 4 minutes ± 30 seconds depending on the physical condition of each patient. Propofol were then immediately administered at an initial maintenance dose of 1.5 mg/kg/hr, with a target sedation depth of RASS +1 to -2, based on the Pain, Agitation/sedation, Delirium, Immobility (rehabilitation/mobilization), and Sleep (disruption) guideline.
Experimental: Ciprofol	Drug: Ciprofol; During the drug administration period, ciprofol were IV infused at loading doses of 0.1 mg/kg, respectively, over 4 minutes ± 30 seconds depending on the physical condition of each patient. Ciprofol were then immediately administered at an initial maintenance dose of 0.3 mg/kg/hr, with a target sedation depth of RASS +1 to -2, based on the Pain, Agitation/sedation, Delirium, Immobility (rehabilitation/mobilization), and Sleep (disruption) guideline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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
Duration of mechanical ventilation	Duration of mechanical ventilation: defined as the time from randomization to extubation in 28 days	from randomization until the date of first extubation or date of death from any cause, whichever came first, assessed up to 28 days
Extubation time	defined as time from stopping the study drug to extubation, or death from any cause; not applicable for patients who withdraw early or do not plan to extubate after stopping the drug, in 28 days;	from stopping the study drug to extubation, or death from any cause, or 28 days
Awakening time	defined as the time from stopping the study drug to awakening from sedation (RASS ≥ 0) in 24h after stopping the drug. If RASS is ≥ 0 at the time of stopping the drug, the awakening time is recorded as 0; If RASS is less than 0 in 24h after stopping the drug, the awakening time is recorded as 24h;	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 24h after stopping the drug.
Length of ICU stay	defined as the time from randomization to discharge from the ICU;	the time from randomization 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 randomization 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, or as determined by the investigator; and the use of vasopressor medications will be recorded;	from randomization to 48 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 randomization to 48 hours after the end of study drug administration

Collaborators and Investigators

• Sponsor: Zhongda Hospital
• Collaborators: First People's Hospital of Hangzhou; The First Affiliated Hospital of Nanchang University; First Affiliated Hospital, Sun Yat-Sen University; First Affiliated Hospital Xi'an Jiaotong University; Zhongnan Hospital; Henan Provincial People's Hospital; Xuzhou Central Hospital; Hebei Medical University Fourth Hospital; Renmin Hospital of Wuhan University; Sichuan Academy of Medical Sciences; Fifth Affiliated Hospital of Xinjiang Medical University; China-Japan Union Hospital, Jilin University; The First People's Hospital of Lianyungang; Second Affiliated Hospital of Suzhou University; Jiangxi Provincial People's Hopital; First Affiliated Hospital of Suzhou Medical College; Taian City Central Hospital; Huai'an First People's Hospital; The First People's Hospital of Zunyi; First Affiliated Hospital of Kunming Medical University; Suqian First Hospital; The First Affiliated Hospital of Air Force Medicial University; Zhongnan University Xiangya Second Hospital; First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital); Anhui provincial chest hospital; The Guangxi Zhuang Autonomous Region People's Hospital; The Ninth People's Hospital of Suzhou; Xuzhou Medical University Hospital; Jinan City People's Hospital; Jiangsu Subei People's Hospital; The first People's Hospital of Yancheng City

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ICU; Sedation; Propofol; Mechanical Ventilation; Ciprofol
• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol; (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol
• Other Study ID Numbers: SAME study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No