A Study of Remimazolam Tosilate for Sedation in the ICU

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in the Intensive Care Unit (ICU) - a Multicenter, Randomized, Single Blind, Dose Finding Phase II Clinical Trial

Conditions
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Sedation in the ICU

Intervention / Treatment
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* Drug: Remimazolam Tosilate
* Drug: Remimazolam Tosilate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients or their guardians are able to provide a written informed consent 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 Meet the age criteria, male or female Meet the BMI criteria Exclusion Criteria: Deep sedation is required, or continuous sedation is not needed during the study process Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness Subjects with a history of drug abuse Subjects after neurosurgery operation Organ failure before randomization Abnormal values of the laboratory examination Abnormal blood pressure and heart rate during screening Allergic to relevant drugs ingredient or component Pregnant or nursing women Subjects who has participated in clinical trials of other interventions recently

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A：Remimazolam Tosilate<br> | Drug: Remimazolam Tosilate<br>* 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<br>|
| Experimental: B：Remimazolam Tosilate<br> | Drug: Remimazolam Tosilate<br>* Loading dose: 0.08mg/kg, Drug: Propofol Injection Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.2mg/kg/h IV of Propofol Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time maintaining target sedation in the entire drug administering time. |  | within 24 hours after administration of research drug | 
| 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 | 
| Wake-up time. |  | within 8 hours after stopping the research drug | 
| Evaluation of nursing difficulty. |  | follow-up period (approx. 5-10 minutes) | 
| Mechanical ventilation time. |  | at the time of extubation |