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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
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.
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
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.
Time frame: Within 7 days of the study began
Invasive ventilator free time within 7 days
The time without invasive ventilation within 7 days of the study began
Time frame: 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
Time frame: Within 7 days of the study began
Incidence of unexpected extubation
Incidence of all extubation not planned by the attending physician
Time frame: Within 7 days of the study began
Proportion of delirium in the ICU
Delirium as a percentage of all evaluable mental patients in the ICU
Time frame: During ICU stay
Non-ICU survival time within 28 days
The time of survival outside of ICU within 7 days of the study began
Time frame: Within 28 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
Time frame: Within 28 days of the study began
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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
Time frame: Within 7 days of the study began