A Study of Remimazolam Tosilate for Prolonged Sedation in the ICU

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating the Efficacy and Safety of Remimazolam Tosilate for Injection for Prolonged Mechanical Ventilation Sedation in the Intensive Care Unit (ICU) - A Non-randomized, Multicenter, Single-arm, Open-label, Proof-of-concept, Phase I/II Clinical Trial

Conditions
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Sedation in the ICU

Intervention / Treatment
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* 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 Age ≥ 18 and ≤ 80 years, male or female Body mass index (BMI) > 18 and < 30 kg/m2 Exclusion Criteria: participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation； Suffering from mental disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction; Organ failure during screening period； Subjects who were receiving dialysis during the screening period or who were expected to require dialysis treatment during the study period; History of epilepsy or status epilepticus; Subjects with a history of drug abuse； Myasthenia gravis or a history of myasthenia gravis; severe arrhythmias or heart disease; Subjects after neurosurgery operation； participants who did not require continuous sedation during mechanical ventilation for endotracheal intubation; Abnormal values of the laboratory examination Subjects who required vasopressor medication to maintain normotensive blood pressure during the screening period (excluding subjects who used vasopressor medication only during surgery); Allergic to relevant drugs ingredient or component; Pregnant or nursing women; Subjects who has participated in clinical trials of other interventions recently; Other conditions deemed unsuitable to be included.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam Tosilate<br>IV of Remimazolam Tosilate | Drug: Remimazolam Tosilate<br>* 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<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 72 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 72 hours after administration of research drug | 
| 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 | 
| Wake-up time. |  | after stopping the research drug | 
| Evaluation of nursing difficulty. |  | follow-up period (approx. 5-10 minutes) | 
| Mechanical ventilation time. |  | at the time of extubation |