Sedation in ICU Patients With Mechanical Ventilation

Launched by ZHONGDA HOSPITAL · Aug 5, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on comparing two medications used for sedation in patients who are on mechanical ventilation in the Intensive Care Unit (ICU). The trial is specifically looking at a new medication called ciprofol, which is similar to the commonly used sedative propofol. Researchers want to see if ciprofol is just as safe and effective as propofol for keeping patients comfortable while they are receiving respiratory support.

To be eligible for this study, participants need to be adults between the ages of 18 and 80 who are being admitted to the ICU and will require sedation for 6 to 24 hours. It's important that patients or their family members understand the purpose of the study and agree to participate by signing consent forms. Those with certain health conditions, such as severe heart or liver problems, or those who are pregnant, will not be included. If you join the study, you can expect to be closely monitored while receiving either ciprofol or propofol, and your care team will ensure your comfort and safety throughout the process.

Gender

ALL

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.