Pharmacokinetic Study of Continuous Infusion of Remazolam in Mechanically Ventilated Patients in ICU

Study Overview
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Brief Summary
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To study the pharmacokinetics of continuous infusion of remazolam in ICU mechanically ventilated critically ill patients, and the characteristics of PK in patients with liver failure; to explore whether liver failure affects the metabolism of remazolam by established population pharmacokinetics.

Official Title
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Pharmacokinetic Study of Continuous Infusion of Remazolam in Mechanically Ventilated Patients in ICU : Establishment of Population Pharmacokinetic Model and Exploration of Clinical Influencing Factors

Conditions
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Intensive Care Unit, Mechanical Ventilation, Anesthesia, Liver Failure, Pharmacokinetics

Intervention / Treatment
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* Drug: Remimazolam 0.1mg/kg/h
* Drug: Remimazolam 0.3mg/kg/h
* Drug: Remimazolam 0.5mg/kg/h


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to ICU for tracheal intubation and mechanical; Patients aged >18 years; Patients with expected mechanical ventialation time >24 hours. Exclusion Criteria: Patients on long-term anti-anxiety medication or sleeping pills; Patients with known or suspected hypersensitivity to remimazolam; Patients with severe central nervous system diseases; Patients who do not wish to sign the informed consent form.

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam 0.1mg/kg/h<br>Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.1 mg/kg/h. | Drug: Remimazolam 0.1mg/kg/h<br>* Remimazolam Tosilate for Injection(36mg)<br>|
| Experimental: Remimazolam 0.3mg/kg/h<br>Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.3 mg/kg/h. | Drug: Remimazolam 0.3mg/kg/h<br>* Remimazolam Tosilate for Injection(36mg)<br>|
| Experimental: Remimazolam 0.5mg/kg/h<br>Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.5 mg/kg/h. | Drug: Remimazolam 0.5mg/kg/h<br>* Remimazolam Tosilate for Injection(36mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of Remimazolam | Plasma concentration of Remimazolam | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions | Adverse reaction that patients experience with the medication,such as hypertension,hypotension,rapid heart rate,slow heart rate | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remimazolam, Intensive Care Unit, Mechanical Ventilation, Anesthesia, Sedation, Liver Failure, Pharmacokinetics