Mechanical Ventilation, Sedative
Conditions
Brief summary
A randomized non-inferior trial comparing remimazolam besylate with propofol for short-term sedation during invasive mechanical ventilation in intensive care units
Interventions
DRUGRemimazolam besylate
0\ 2.0mg/kg/h
DRUGPropofol
0.3\ 4.0mg/kg/h
DRUGRemifentanil
1.5\ 12μg/kg/h
Sponsors
Yichang Humanwell Pharmaceutical Co., Ltd., China
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 * Body mass index (BMI) ≥18 and ≤ 30 kg/m2 * Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on ventilator for at least 6 hours * Requirement for light to moderate sedation (a Richmond agitation-sedation scale score of -2 to 1)
Exclusion criteria
* Refusal to be included * Allergy or unsuitability to any composition of study drugs or remifentanil * Living expectancy less than 48 hours * Myasthenia gravis * Status asthmaticus * Abdominal compartment syndrome * Serious hepatic dysfunction (CTP 10-15); * Chronic kidney disease with glomerular filtration rate (GFR) \< 29 ml/min/1.73m2 * Mean blood pressure less than 65 mm Hg or the need of a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain Mean blood pressure ≥ 65 mm Hg * Possible requirement for surgery or bedside tracheostomy in 24 hours * Possible requirement for renal replacement therapy in 24 hours * Acute severe neurological disorder and any other condition interfering with sedation assessment * Abuse of controlled substances or alcohol * Pregnancy or lactation * Inclusion in another interventional trial in the past 30 days * Other conditions deemed unsuitable to be included
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful sedation | 24 hours | 70% of time in the target sedation range in participants without rescue sedation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of time in the target sedation range without rescue sedation | 24 hours | The percentage of time in the target sedation range without rescue sedation |
| Number of patients needing rescue sedation | 24 hours | Whether participants need sedative drugs other than the study drug to re maintain targeted sedation level |
| Number of patients needing repeated boluses of the study drug | 24 hours | Whether participants need repeated boluses of the study durg other than the loading dose to maintain targeted sedation level |
| The amount of remifentanil in ug/kg/h | 24 hours | The amount of remifentanil in ug/kg/h used in each patient in both groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hypotension | 24 hours | Whether hypotension occurs in participants |
| Delirium | 24 hours | Whether delirium occurs in participants |
Countries
China
Outcome results
None listed