PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Renal Function

Study Overview
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Brief Summary
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Pharmacokinetic/pharmacodynamic profiles of remazolam besylate were compared in patients with impaired and normal renal function in the ICU, and safety was assessed by recording hemodynamic parameters and adverse events.

Official Title
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A Randomized Study of the PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Renal Function

Conditions
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Mechanically Ventilated Patients

Intervention / Treatment
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* Drug: Remimazolam besylate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) ≥18 and ≤ 30 kg/m2 Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on a ventilator for at least 6 hours Requirement for light to moderate sedation (a Richmond agitation-sedation scale score of -2 to 1) Patients with impaired renal function were defined as having a glomerular filtration rate of 30 to 89 ml/min/1.73m2. Patients with normal renal function were defined as having a glomerular filtration rate of 90 to 120 ml/min/1.73m2 Exclusion Criteria: Refusal to be included Allergy or unsuitability to any composition of study drugs or remifentanil Living expectancy less than 48 hours Myasthenia gravis Status asthmaticus Abdominal compartment syndrome Serious hepatic dysfunction (CTP 10-15); Chronic kidney disease with glomerular filtration rate (GFR) < 29 ml/ min/1.73m2 Mean blood pressure less than 65 mm Hg or the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain Mean blood pressure ≥ 65 mm Hg Possible requirement for surgery or bedside tracheostomy in 24 hours Possible requirement for renal replacement therapy in 24 hours Acute severe neurological disorder and any other condition interfering with sedation assessment Abuse of controlled substances or alcohol Pregnancy or lactation

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal renal function group<br> | Drug: Remimazolam besylate<br>* After a loading dose of 0.05mg/kg, a maintaining dose of 0.2mg/kg/h is given; It is recommended to adjust the infusion rate of Remazolam besylate for injection at a amplitude of 0.05mg/kg/h, mainly based on the RASS score of the subjects (the adjustment range is 0-1.0 mg/kg/h, and the maximum infusion rate is not more than 1.0mg/kg/h) until the subjects reach the optimal sedation level (-3≤RASS≤0).<br>|
| Experimental: Renal injury group<br> | Drug: Remimazolam besylate<br>* After a loading dose of 0.05mg/kg, a maintaining dose of 0.2mg/kg/h is given; It is recommended to adjust the infusion rate of Remazolam besylate for injection at a amplitude of 0.05mg/kg/h, mainly based on the RASS score of the subjects (the adjustment range is 0-1.0 mg/kg/h, and the maximum infusion rate is not more than 1.0mg/kg/h) until the subjects reach the optimal sedation level (-3≤RASS≤0).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | peak plasma concentration | Within 24 hours while receiving the study drug | 
| The area under the plasma drug concentration-time curve | The area under the plasma drug concentration-time curve (AUC) | Within 24 hours while receiving the study drug | 
| t1/2 | half-life | Within 24 hours while receiving the study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of time in the target sedation range without rescue sedation | The percentage of time in the target sedation range without rescue sedation | Within 24 hours while receiving the study drug | 
| The number and severity of treatment emergent adverse events (TEAEs) | The number and severity of treatment emergent adverse events (TEAEs) | Within 24 hours while receiving the study drug |