Critically Ill, Deep Sedation
Conditions
Keywords
Remimazolam besylate, Propofol, Intensive care unit, Deep sedation
Brief summary
The purpose of this study is to evaluate the efficacy and safety of remimazolam besylate compared to propofol for sedation in critically ill patients with deep sedation.
Detailed description
This is a single-center, prospective, randomized, controlled study using remimazolam besylate and propofol for sedation in critically ill patients with deep sedation. 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
DRUGRemimazolam Besylate
sedation drugs
DRUGPropofol
Propofol
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 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; * 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; * Expected to have a general anesthesia within 8 hours; * 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 discharged from our ICU, the sedation target was changed, 48 hours after enrollment, or dead, whichever came first | The percentage of time in the target sedation range without rescue sedation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | From the beginning of using study sedatives until being discharged from our ICU, the sedation target was changed, 48 hours after enrollment, or dead, whichever came first | Adverse events |
| 7-day ventitlator free time | From start of study to 7 days | 7-day ventitlator free time |
| Extubation at day 7 | From start of study to 7 days | Extubation at day 7 |
| 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, MD
Outcome results
None listed