Efficacy and Safety of Fospropofol Disodium Versus Propofol for Deep Sedation in Critically Ill Patients
Overview
- Phase
- Phase 2
- Intervention
- Fospropofol disodium for injection
- Conditions
- Critical Illness
- Sponsor
- Xiaobo Yang, MD
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The percentage of time in the target sedation range without rescue sedation
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Xiaobo Yang, MD
Clinical Professor
Wuhan Union Hospital, China
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.
Arms & Interventions
Fospropofol disodium for injection
Patients in the experimental group received fospropofol disodium for injection at an initial infusion rate of 10 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64.
Intervention: Fospropofol disodium for injection
Propofol
Patients in the active comparator group received propofol at an initial infusion rate of 3 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64.
Intervention: Propofol
Outcomes
Primary Outcomes
The percentage of time in the target sedation range without rescue sedation
Time Frame: From start of study to 48 hours
The percentage of time in the target sedation range without rescue sedation
Secondary Outcomes
- 7-day ventilator free time(From start of study to 7 days)
- Length of ICU stay(From start of study to 28 days)
- 28-day mortality(From start of study to 28 days)
- Adverse events(From start of study to 48 hours)
- Success rate of extubation within 7 days(From start of study to 7 days)