Sedation in ICU Patients With Mechanical Ventilation

NCT06538883 | Recruiting DMC

• 1 other identifier: SAME study
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation; Mechanical Ventilation

Keywords

Sedation; Mechanical Ventilation; ICU; Ciprofol; Propofol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

  within the first 24hours of administering the study drug

• Duration of mechanical ventilation

  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

  from stopping the study drug to extubation, or death from any cause, or 28 days

Study Arms (2)

Ciprofol

EXPERIMENTAL

Drug: Ciprofol

Propofol

ACTIVE COMPARATOR

Drug: Sedation with Propofol

Interventions

Sedation with Propofol DRUG

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.

Propofol

Ciprofol DRUG

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.

Ciprofol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.
• \. Patients have the following medical history or evidence of any of the following conditions at screening, which may increase the sedation/anesthesia risk:
• 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.
• 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.
• Patients with grand mal epilepsy and convulsion; a Glasgow coma scale (GCS) ≤ 12 points.

Sponsors & Collaborators

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

Study Sites (1)

Zhongda Hospital, Southeast University, No. 87, Dingjiaqiao Road, Gulou District, Nanjing, 210009, People's Republic of China.

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Fei Peng

CONTACT

15950565786; afei0312@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: August 6, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)