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| Name | Class |
|---|---|
| Yichang Humanwell Pharmaceutical Co., Ltd., China | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal renal function group | Experimental |
| |
| Renal injury group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam besylate | Drug | 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). |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| You Shang, MD | Contact | +8602785351606 | you_shanghust@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Union Hospital | Recruiting | Wuhan | Hubei | 430022 | China |
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|
The number and severity of treatment emergent adverse events (TEAEs) |
| Within 24 hours while receiving the study drug |