Sedation with ciprofol or propofol for adults on mechanical ventilation in the ICU

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

This trial will see if the new sedative ciprofol works as well and is as safe as propofol for adults on mechanical ventilation in the ICU.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 366 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Zhongda Hospital (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06538883 on ClinicalTrials.gov

What this trial studies

This is a multi-center, double-blind, randomized noninferiority trial comparing ciprofol versus propofol for sedation in mechanically ventilated ICU patients. Adults expected to need 6–24 hours of light-to-moderate sedation (target RASS +1 to −2) are randomized to receive one of the two intravenous sedatives. The primary outcome is the rate of successful sedation without hypotension, with safety and hemodynamic events closely monitored. Key exclusions include known allergy to ciprofol, BMI <18 or >30 kg/m2, and patients already sedated for more than three days before enrollment.

Who should consider this trial

Good fit: Adults aged 18–80 in the ICU on mechanical ventilation who are expected to need 6–24 hours of light-to-moderate sedation (target RASS +1 to −2) and who (or their proxy) can give informed consent are ideal candidates.

Not a fit: Patients with known ciprofol allergy, BMI under 18 or over 30 kg/m2, those already sedated more than three days before enrollment, or with conditions that increase anesthesia risk are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, ciprofol could offer an alternative sedative that provides comparable sedation with the potential for fewer hemodynamic side effects like hypotension.

How similar studies have performed: Prior studies outside the ICU setting have shown ciprofol produces sedative effects similar to propofol, but randomized data in mechanically ventilated ICU patients remain limited.

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.

Where this trial is running

Nanjing, Jiangsu

• Zhongda Hospital, Southeast University, No. 87, Dingjiaqiao Road, Gulou District, Nanjing, 210009, People's Republic of China. — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Fei Peng

Conditions: Sedation, Mechanical Ventilation, ICU, Ciprofol, Propofol