Back to resultsEfficacy and Safety of Fospropofol Disodium Versus Propofol for Sedation in Mechanically Ventilated ICU Patients
Primary Purpose
Critical Illness
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fospropofol disodium for injection
Propofol
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring Fospropofol, Propofol, Sedation, Intensive care unit
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);
Sites / Locations
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fospropofol disodium for injection
propofol
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Percentage of time spent reaching sedation goals
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 Outcome Measures
Invasive ventilator free time within 7 days
The time without invasive ventilation within 7 days of the study began
Rate of successful extubation within 7 days
The proportion of participants who experienced successful extubation within 7 days of the study began
Incidence of unexpected extubation
Incidence of all extubation not planned by the attending physician
Proportion of delirium in the ICU
Delirium as a percentage of all evaluable mental patients in the ICU
Non-ICU survival time within 28 days
The time of survival outside of ICU within 7 days of the study began
Case fatality rate within 28 days
After follow-up, the fatality rates of all enrolled patients (including those still in ICU, transferred out and discharge) within 28 days of the study began
Percentage of time spent that trial drug was discontinued due to adverse events
Percentage of time the trial drug was discontinued due to any adverse event suspected to be related to the trial drug
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05491278
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
September 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaobo Yang, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Fospropofol, Propofol, Sedation, Intensive care unit
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fospropofol disodium for injection
Arm Type
Experimental
Arm Description
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.
Arm Title
propofol
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Fospropofol disodium for injection
Other Intervention Name(s)
Remifentanil
Intervention Description
Fospropofol disodium for injection continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Remifentanil
Intervention Description
Propofol for injection continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician.
Primary Outcome Measure Information:
Title
Percentage of time spent reaching sedation goals
Description
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.
Time Frame
Within 7 days of the study began
Secondary Outcome Measure Information:
Title
Invasive ventilator free time within 7 days
Description
The time without invasive ventilation within 7 days of the study began
Time Frame
Within 7 days of the study began
Title
Rate of successful extubation within 7 days
Description
The proportion of participants who experienced successful extubation within 7 days of the study began
Time Frame
Within 7 days of the study began
Title
Incidence of unexpected extubation
Description
Incidence of all extubation not planned by the attending physician
Time Frame
Within 7 days of the study began
Title
Proportion of delirium in the ICU
Description
Delirium as a percentage of all evaluable mental patients in the ICU
Time Frame
During ICU stay
Title
Non-ICU survival time within 28 days
Description
The time of survival outside of ICU within 7 days of the study began
Time Frame
Within 28 days of the study began
Title
Case fatality rate within 28 days
Description
After follow-up, the fatality rates of all enrolled patients (including those still in ICU, transferred out and discharge) within 28 days of the study began
Time Frame
Within 28 days of the study began
Title
Percentage of time spent that trial drug was discontinued due to adverse events
Description
Percentage of time the trial drug was discontinued due to any adverse event suspected to be related to the trial drug
Time Frame
Within 7 days of the study began
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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);
Facility Information:
Facility Name
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efficacy and Safety of Fospropofol Disodium Versus Propofol for Sedation in Mechanically Ventilated ICU Patients
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