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Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical Ventilation: a prospective, single center, randomized, double-blind, comparative study.

Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical Ventilation: a prospective, single center, randomized, double-blind, comparative study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066951
Enrollment
Unknown
Registered
2022-12-22
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Sedation in ICU Patients with Mechanical Ventilation

Interventions

Group ciprofol:ciprofol sedation
Group propofol:propofol sedation

Sponsors

Shanghai Fourth People's Hospital Affiliated to Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) 18 years = age = 85 years, 18 kg / m2 = BMI = 30 kg / m2, gender unlimited; (2) Before enrollment, patients were intubated, mechanically ventilated for no more than 96 hours, expected to receive sedation for = 24 hours, and sedation target RASS score: - 3 to 0 points; (3) The patients' families will fully understand the purpose and significance of the trial, participate voluntarily and sign the informed consent form;

Exclusion criteria

Exclusion criteria: (3) Acute severe neuropsychiatric disease and various conditions interfering with RASS scores; (4) Systolic blood pressure remains less than 90 mmHg with high doses of a single vasoactive drug to maintain blood pressure or two or more vasoactive drugs to maintain blood pressure; (5) Heart rate less than 50 beats / min, second - or third degree heart block and no pacemaker; (6) Cardiac function class IV (NYHA class) or severe cardiomyopathy; (7) Severe liver dysfunction or acute liver failure; (8) Chronic alcohol or drug use; (9) Patients with known allergies to eggs, soy products, or propofol and patients with contraindications to propofol, opioids, and their reliever medications; (10) Had contraindications to deep sedation, or had a previous sedation accident; (11) Pregnant or lactating women; (12) The investigator considered the evaluation of the patient as not suitable for inclusion in the study for various reasons;

Design outcomes

Primary

MeasureTime frame
Percentage of time on qualified sedation;

Secondary

MeasureTime frame
Heart Rate;Blood Pressure;Inflammatory biomarkers;

Countries

China

Contacts

Public ContactSun Xiaoxiao

Shanghai Fourth People's Hospital Affiliated to Tongji University

Xiaoxiaosun1522@163.com13012869373

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026