Sedation in ICU Patients With Mechanical Ventilation

Southeast University

Status: Not yet enrolling

Conditions: Respiration, Artificial; Hypnotics and Sedatives

Treatments: Drug: Sedation with Propofol; Drug: Sedation with Ciprofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06538883

SAME study

Details and patient eligibility

About

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.

Enrollment: 366 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

2. Patients have the following medical history or evidence of any of the following conditions at screening, which may increase the sedation/anesthesia risk:

3. 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.

4. 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.

5. Patients with grand mal epilepsy and convulsion; a Glasgow coma scale (GCS) ≤ 12 points.

6. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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366 participants in 2 patient groups

Ciprofol

Experimental group

Treatment:

Drug: Sedation with Ciprofol

Propofol

Active Comparator group

Treatment:

Drug: Sedation with Propofol