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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Critical Illness

Intervention / Treatment
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* Drug: Fospropofol disodium for injection
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fospropofol disodium for injection<br>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. | Drug: Fospropofol disodium for injection<br>* 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.<br>|
| Active Comparator: Propofol<br>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. | Drug: Propofol<br>* Propofol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of time in the target sedation range without rescue sedation | The percentage of time in the target sedation range without rescue sedation | From start of study to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Incidence rate of adverse events | From start of study to 48 hours | 
| 7-day ventilator free time | 7-day ventilator free time | From start of study to 7 days | 
| Success rate of extubation within 7 days | Success rate of extubation within 7 days | From start of study to 7 days | 
| Length of ICU stay | Length of ICU stay | From start of study to 28 days | 
| 28-day mortality | 28-day mortality | From start of study to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep sedation, Fospropofol, Propofol, Intensive care unit