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Cipepofol versus propofol for sdedation in intensive care unit (ICU) patients undergoing long-term mechanical ventilation:a multicenter, single-blind, randomized controlled study.

Cipepofol versus propofol for sdedation in intensive care unit (ICU) patients undergoing long-term mechanical ventilation:a multicenter, single-blind, randomized controlled study.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088671
Enrollment
Unknown
Registered
2024-08-23
Start date
2024-12-11
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation of patients in the ICU

Interventions

The Cipepofol Group:The Cipepofol will be administered for sedation
The Propofol Group:The Propofol will be administered for sedation

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. ICU patients requiring mechanical ventilation; 2.The target RASS ranged from 0 to -3, and the expected sedation time was more than 24 hours after randomization; 3. 18 years old = age < 80 years old; Gender is unrestricted; 4. 18 kg/m2 = BMI = 30 kg/m2; 5. Patients or their family members have a full comprehension of the purpose and significance of this trial, voluntarily participate in this clinical trial, and sign an informed consent.

Exclusion criteria

Exclusion criteria: 1. Contraindications or allergies to the study drugs; 2. Acute severe neurological illness and any other conditions that interfere with the RASS assessment; 3. Cardiovascular diseases: bradycardia and/or heart rate = 50 beats/min requiring drug treatment; Degree II-III atrioventricular block (excluding patients with pacemakers); Acute and chronic myocarditis; 4. Acute hepatitis or severe liver dysfunction; 5. Chronic kidney disease patients with glomerular filtration rate GFR = 30 mL/(min * 1.73 m2); 6. Patients with high paraplegia and general paralysis; 7. Patients with uncontrolled hemodynamics (such as patients with systolic blood pressure less than 90 mmHg despite appropriate intravenous fluids and continuous infusion of two vasopressors, or patients with shock, etc.); 8. Previous history of abuse of nerve drugs and narcotic drugs; History of alcohol abuse and long-term use of psychotropic drugs within 3 months before the screening period; 9. Pregnancy and lactation; 10. Participation in other drug clinical trials within 1 month before screening; 11. Any other circumstances in which the patient was judged by the investigator to be ineligible for participation in the trial.

Design outcomes

Primary

MeasureTime frame
The success rate of sedation;

Secondary

MeasureTime frame
The compliance rate of early sedation;The usage of study drug;The duration of Mechanical ventilation;Extubation time;Recovery Time to Full Consciousness;Length of ICU stay;Patient survival;The usage of vasoactive drugs;Changes in triglyceride levels;

Countries

China

Contacts

Public ContactYan Kang

West China Hospital, Sichuan University

kangyan_hx@163.com+86 189 8060 1566

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026