Clinical trial NCT05491278: Efficacy and Safety of Fospropofol Disodium Versus Propofol for Sedation in Mechanically Ventilated ICU Patients
Official title: Efficacy and Safety of Fospropofol Disodium Versus Propofol for Sedation in Mechanically Ventilated ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Critical Illness
Keywords: Fospropofol
Propofol
Sedation
Intensive care unit
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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);

Primary outcomes:
measure: Percentage of time spent reaching sedation goals
timeFrame: Within 7 days of the study began
Secondary outcomes:
measure: Invasive ventilator free time within 7 days
timeFrame: Within 7 days of the study began
measure: Rate of successful extubation within 7 days
timeFrame: Within 7 days of the study began
measure: Incidence of unexpected extubation
timeFrame: Within 7 days of the study began
measure: Proportion of delirium in the ICU
timeFrame: During ICU stay
measure: Non-ICU survival time within 28 days
timeFrame: Within 28 days of the study began
measure: Case fatality rate within 28 days
timeFrame: Within 28 days of the study began
measure: Percentage of time spent that trial drug was discontinued due to adverse events
timeFrame: Within 7 days of the study began
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study officials:
References: