Comparing fospropofol and propofol for deep sedation in critically ill patients

Efficacy and Safety of Fospropofol Disodium Versus Propofol for Deep Sedation in Critically Ill Patients

This study tests whether fospropofol is as safe and effective as propofol for keeping critically ill patients deeply sedated while they are on a ventilator in the ICU.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Wuhan Union Hospital, China (other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05870514 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of fospropofol disodium compared to propofol for deep sedation in mechanically ventilated patients in the ICU. It is a randomized, open-label trial where participants are assigned to receive either fospropofol or propofol, with remifentanil co-administered. The study aims to monitor the efficacy and safety profiles of both sedatives over a period of deep sedation lasting at least 8 hours.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who are expected to require deep sedation for at least 8 hours.

Not a fit: Patients with certain contraindications, such as severe hepatic dysfunction or unstable cardiovascular conditions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective sedation option for critically ill patients requiring prolonged sedation.

How similar studies have performed: While the efficacy of propofol is well-established, the use of fospropofol is less common, making this approach relatively novel.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 and ≤ 80 years; Expected to require deep sedation ≥8 hours; Requirement for deep sedation (a Narcotrend index between 13 and 64).

Exclusion Criteria:

* Body mass index (BMI) \<18 or \>30 kg/m2; Contraindicate or allergic to study drugs; Moribund state; Expected to have a general anesthesia within 8 hours; Myasthenia gravis; Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C); Chronic kidney disease with glomerular filtration rate (GFR) \< 29 ml/min/1.73m2; Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors; Acute severe neurological disorder and any other condition interfering with RASS assessment; Pregnancy or lactation; Unstable angina; Acute myocardial infarction; Left ventricular ejection fraction less than 30%; Heart rate less than 50 beats/min; Second- or third-degree heart block in the absence of a pacemaker; Alcohol abuse or drug abuse.

Where this trial is running

Wuhan, Hubei

• Wuhan Union Hospital — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Study coordinator: Xiaobo Yang

Conditions: Critical Illness, Deep sedation, Fospropofol, Propofol, Intensive care unit