Status:
NOT_YET_RECRUITING
Sedation in ICU Patients With Mechanical Ventilation
Lead Sponsor:
Zhongda Hospital
Collaborating Sponsors:
The First Affiliated Hospital of Air Force Medicial University
First Affiliated Hospital, Sun Yat-Sen University
Conditions:
Respiration, Artificial
Hypnotics and Sedatives
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ha...
Eligibility Criteria
Inclusion
- Inclusion criteria (patients who met all the following criteria):
- 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.
- 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:
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT06538883
Start Date
August 1 2024
End Date
July 30 2026
Last Update
August 6 2024
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