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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam 0.1mg/kg/h | Experimental | Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.1 mg/kg/h. |
|
| Remimazolam 0.3mg/kg/h | Experimental | Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.3 mg/kg/h. |
|
| Remimazolam 0.5mg/kg/h | Experimental | Participants were first induced with 5mg in 1-min intravenous injection and then maintained at 0.5 mg/kg/h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam 0.1mg/kg/h | Drug | Remimazolam Tosilate for Injection(36mg) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of Remimazolam | Plasma concentration of Remimazolam | 24 hours |
| 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 |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | 225500 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40517312 | Derived | Hu J, Zhao Y, Shao L, Zhang W, Wang H, Liu Y, Su M, Zuo X. Pharmacokinetic Properties and Therapeutic Effectiveness of Remimazolam in ICU Patients With Mechanical Ventilation: A Preliminary Study. Pharmacol Res Perspect. 2025 Jun;13(3):e70130. doi: 10.1002/prp2.70130. |
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| Remimazolam 0.3mg/kg/h |
| Drug |
Remimazolam Tosilate for Injection(36mg) |
|
| Remimazolam 0.5mg/kg/h | Drug | Remimazolam Tosilate for Injection(36mg) |
|
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
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