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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
Propofol
Wuhan Union Hospital
Wuhan, Hubei, China
RECRUITINGThe percentage of time in the target sedation range without rescue sedation
The percentage of time in the target sedation range without rescue sedation
Time frame: From start of study to 48 hours
Adverse events
Incidence rate of adverse events
Time frame: From start of study to 48 hours
7-day ventilator free time
7-day ventilator free time
Time frame: From start of study to 7 days
Success rate of extubation within 7 days
Success rate of extubation within 7 days
Time frame: From start of study to 7 days
Length of ICU stay
Length of ICU stay
Time frame: From start of study to 28 days
28-day mortality
28-day mortality
Time frame: From start of study to 28 days
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