Sedation in the ICU
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.
Interventions
Loading dose: 0.08mg/kg Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1-0.2mg/kg/h
DRUGPropofol Medium and Long Chain Fat Emulsion Injection
Loading dose: 0.3-0.5mg/kg Maintenance dose: IV Propofol Medium and Long Chain Fat Emulsion Injection, dose range 0.3-4.0mg/kg/h, increment or decrement of 0.3-0.6mg/kg/h
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients and/or their guardians are able to provide a written informed consent, understand and agree to comply with the study requirements and protocol. 2. Subjects have been treated with endotracheal intubation and mechanical ventilation, and are expected to receive sedation after randomization at least 6 hours. The target sedation level during the period is -2 ≤ RASS ≤ +1. 3. 18 years to 80 years old, male or female. 4. 18 kg/m2 ≤ BMI ≤ 30 kg/m2.
Exclusion criteria
1. Deep sedation is required, or continuous sedation is not needed during the study process. 2. Participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation. 3. History of epilepsy or status epilepticus. 4. Myasthenia gravis or a history of myasthenia gravis. 5. Severe arrhythmias or heart disease; the circulatory system is unstable. 6. Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness. 7. Subjects with a history of drug abuse. 8. Organ failure before randomization. 9. Abnormal values of the laboratory examination. 10. Allergic to relevant drugs ingredient or component. 11. Pregnant or nursing women. 12. Subjects who has participated in clinical trials of other interventions recently. 13. Other conditions deemed unsuitable to be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of sedation success, sedation success is defined as the percentage of time maintaining target sedation in the entire drug administering time ≥ 70% without rescue sedation. | within 24 hours after administration of research drug |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects receiving rescue sedation | within 24 hours after administration of research drug |
| The number of additional doses of the research drug | within 24 hours after administration of research drug] |
| The total dosage of Fentanyl | within 24 hours after administration of research drug |
| Percentage of time maintaining target sedation in the entire drug administering time. | within 24 hours after administration of research drug |
| Stopping the research drug to extubation time. | within 6 hours after stopping the research drug |
| Nursing scale score | follow-up period (approx. 5-10 minutes) |
| Wake-up time. | within 6 hours after stopping the research drug |
Countries
China
Outcome results
None listed