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

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

The purpose of this study is to evaluate the efficacy and safety of fospropofol disodium for injection compared to propofol for deep sedation in mechanically ventilated ICU patients.

This is a randomized, open-label, small sample study using fospropofol disodium and propofol for deep sedation in mechanically ventilated ICU patients. Subjects are randomized to different treatment groups (including 1 for fospropofol disodium and 1 for propofol). Remifentanil is co-administered with fospropofol or propofol. Efficacy and safety profiles of fospropofol disodium and propofol are to be monitoted.

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.