Critical Illness
Conditions
Keywords
Remimazolam besylate, Propofol, Intensive care unit, Mechanical ventilation
Brief summary
The purpose of this study is to evaluate the efficacy and safety of remimazolam compared to propofol for sedation in mechanically ventilated ICU patients.
Detailed description
This is a single-center, prospective, randomized, controlled pilot study using remimazolam and propofol for sedation in mechanically ventilated ICU patients. Subjects are randomized to remimazolam group and propofol group in a 1:1 ratio. Remifentanil is administered as the analgesic. Efficacy and safety profiles of remimazolam besylate are to be evaluated.
Interventions
DRUGSedation drugs
Different sedation drugs
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 and ≤ 75 years; * Intubated and mechanically ventilated ≤96 hours before enrollment； * Expected to require continuous invasive ventilation and sedation ≥24 hours; * Requirement for light to moderate sedation (a RASS score of -3 to 0).
Exclusion criteria
* Body mass index (BMI) \<18 or \>30 kg/m2; * Acute severe neurological disorder and any other condition interfering with RASS assessment; * Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors; * Heart rate less than 50 beats/min; * Second- or third-degree heart block in the absence of a pacemaker; * Unstable angina; * Acute myocardial infarction; * Left ventricular ejection fraction less than 30%; * Contraindicate or allergic to study drugs; * Moribund state; * Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C); * Chronic kidney disease with glomerular filtration rate (GFR) \< 60 ml/min/1.73m2; * Alcohol abuse; * Myasthenia gravis; * Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of time in the target sedation range without rescue sedation | From the beginning of using study sedatives until being extubated, being discharged from our ICU, the study drug was stopped for 24 hours by physicians, or 7 days after enrollment, whichever came first | The percentage of time in the target sedation range without rescue sedation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 7-day ventitlator free time | From start of study to 7 days | 7-day ventitlator free time |
Countries
China
Outcome results
None listed