Critical Illness
Conditions
Keywords
Deep sedation, Fospropofol, Propofol, Intensive care unit
Brief summary
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
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.
Interventions
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.
DRUGPropofol
Propofol
Sponsors
Xiaobo Yang, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of time in the target sedation range without rescue sedation | From start of study to 48 hours | The percentage of time in the target sedation range without rescue sedation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | From start of study to 48 hours | Incidence rate of adverse events |
| 7-day ventilator free time | From start of study to 7 days | 7-day ventilator free time |
| Success rate of extubation within 7 days | From start of study to 7 days | Success rate of extubation within 7 days |
| Length of ICU stay | From start of study to 28 days | Length of ICU stay |
| 28-day mortality | From start of study to 28 days | 28-day mortality |
Countries
China
Contacts
Primary ContactXiaobo Yang
Backup ContactYou Shang
Outcome results
None listed