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 prolonged sedation(≥72h) during mechanical ventilation 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
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients or their guardians are able to provide a written informed consent 2. Subjects have been treated with endotracheal intubation and mechanical ventilation, and is expected to receive sedation after randomization. The target level and duration of sedation meet the criteria 3. Age ≥ 18 and ≤ 80 years, male or female 4. Body mass index (BMI) \> 18 and \< 30 kg/m2
Exclusion criteria
1. participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation； 2. Suffering from mental disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction; 3. Organ failure during screening period； 4. Subjects who were receiving dialysis during the screening period or who were expected to require dialysis treatment during the study period; 5. History of epilepsy or status epilepticus; 6. Subjects with a history of drug abuse； 7. Myasthenia gravis or a history of myasthenia gravis; 8. severe arrhythmias or heart disease; 9. Subjects after neurosurgery operation； 10. participants who did not require continuous sedation during mechanical ventilation for endotracheal intubation; 11. Abnormal values of the laboratory examination 12. Subjects who required vasopressor medication to maintain normotensive blood pressure during the screening period (excluding subjects who used vasopressor medication only during surgery); 13. Allergic to relevant drugs ingredient or component; 14. Pregnant or nursing women; 15. Subjects who has participated in clinical trials of other interventions recently; 16. 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 72 hours after administration of research drug |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects receiving rescue sedation and the average dosage of rescue sedation | within 72 hours after administration of research drug |
| Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesia | within 72 hours after administration of research drug |
| Percentage of time maintaining target sedation in the entire drug administering time. | within 72 hours after administration of research drug |
| Evaluation of nursing difficulty. | follow-up period (approx. 5-10 minutes) |
| Mechanical ventilation time. | at the time of extubation |
| Wake-up time. | after stopping the research drug |
Countries
China
Outcome results
None listed