Sedation in the ICU
Conditions
Brief summary
The purpose of this study is to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.
Interventions
Loading dose: 0.08mg/kg IV of Remimazolam Tosilate, Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1mg/kg/h
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
This is a Multicenter, Randomized, Single Blind, Dose Finding, Phase II Clinical Trial to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU
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. Meet the age criteria, male or female 4. Meet the BMI criteria
Exclusion criteria
1. Deep sedation is required, or continuous sedation is not needed during the study process 2. Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness 3. Subjects with a history of drug abuse 4. Subjects after neurosurgery operation 5. Organ failure before randomization 6. Abnormal values of the laboratory examination 7. Abnormal blood pressure and heart rate during screening 8. Allergic to relevant drugs ingredient or component 9. Pregnant or nursing women 10. Subjects who has participated in clinical trials of other interventions recently
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 and the average dosage of rescue sedation | within 24 hours after administration of research drug |
| Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesiaassessment time point after drug administering. | within 24 hours after administration of research drug |
| The number of times to change the infusion rate | 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 |
| Evaluation of nursing difficulty. | follow-up period (approx. 5-10 minutes) |
| Mechanical ventilation time. | at the time of extubation |
| Wake-up time. | within 8 hours after stopping the research drug |
Countries
China
Outcome results
None listed