Efficacy and Safety of Fospropofol Disodium Versus Propofol for Sedation in Mechanically Ventilated ICU Patients
Overview
- Phase
- Phase 2
- Intervention
- Fospropofol disodium for injection
- Conditions
- Critical Illness
- Sponsor
- Xiaobo Yang, MD
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Percentage of time spent reaching sedation goals
- Status
- Completed
- 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 sedation in mechanically ventilated ICU patients.
Detailed Description
This is a randomized, open-label, small sample study using fospropofol disodium and propofol for 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 are to be evaluated.
Investigators
Xiaobo Yang, MD
Clinical Professor
Wuhan Union Hospital, China
Eligibility Criteria
Inclusion Criteria
- •Patients aged \>= 18 and \<= 75 years; Endotracheal intubated; Patients currently on mechanical ventilation \<= 96 hours and expected to be mechanically ventilated \>= 24 hours; Demand for light/moderate sedation (a RASS score of -3 to 0).
Exclusion Criteria
- •Informed Consent is unsigned； Participated in any other interventional research within 3 months; Tracheostomy; BMI \<= 18 and \>= 35 kilograms per square meter Pregnant; Lactant; Known or suspected allergy to various components of the study drug or to opioids and their salvage drugs, or other diseases (such as pancreatitis associated with hyperlipidemia) for which lipid emulsion should not be used; Patients who cannot be evaluated for RASS for various reasons (such as mental illness, acquired or congenital mental retardation, deafness, severe neuromuscular disease, Parkinson's disease, Huntington's disease, Alzheimer's disease, cerebrovascular disease, coma, or severe cognitive impairment due to structural diseases such as stroke, intracranial hemorrhage, head injury, malignancy, hypoxic brain injury, or cerebral edema); Patients with an expected survival period of less than 48 hours; Severe hepatic insufficiency (CTP score is 10-15 points); Chronic kidney disease (CKD grade 3 above); Unstable angina pectoris or acute myocardial infarction; Left ventricular ejection fraction \<= 30%; Heart rate \< 50bpm(intravenous pumping of isoproterenol \<4ug/min, heart rate ≥50bpm may not be excluded); Type 2 second-degree or third-degree atrioventricular block (except those implanted a pacemaker); Two vasoconstrictors are used to maintain SBP above 90mmHg after sufficient fluid resuscitation; Myasthenia gravis; Patients with a history of drug abuse, drug abuse, alcohol abuse and long-term use of psychotropic drugs within 2 years before the screening period. Binge drinking is defined as regular drinking more than 14 times per week (1 time = 150ml of wine or 360ml of beer or 45ml of spirits);
Arms & Interventions
Fospropofol disodium for injection
Fospropofol disodium continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for analgesia.The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician.
Intervention: Fospropofol disodium for injection
propofol
Propofol continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for analgesia. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician.
Intervention: Propofol
Outcomes
Primary Outcomes
Percentage of time spent reaching sedation goals
Time Frame: Within 7 days of the study began
Proportion of RASS assessment time points for subjects meeting target sedation levels among all RASS assessment time points during study drug administration without rescue sedation.
Secondary Outcomes
- Rate of successful extubation within 7 days(Within 7 days of the study began)
- Incidence of unexpected extubation(Within 7 days of the study began)
- Proportion of delirium in the ICU(During ICU stay)
- Non-ICU survival time within 28 days(Within 28 days of the study began)
- Invasive ventilator free time within 7 days(Within 7 days of the study began)
- Case fatality rate within 28 days(Within 28 days of the study began)
- Percentage of time spent that trial drug was discontinued due to adverse events(Within 7 days of the study began)