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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001113-32 | EudraCT Number |
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| Name | Class |
|---|---|
| Aptiv Solutions | INDUSTRY |
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This phase II study in patients undergoing elective cardiac surgery will evaluate the efficacy, safety, and pharmacokinetics of remimazolam, compared with propofol and sevoflurane, during the induction and maintenance of general anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol | Active Comparator | Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil. |
|
| Remimazolam 6 mg/kg/hr | Experimental | Induction: Remimazolam 6 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil. |
|
| Remimazolam 12 mg/kg/hr | Experimental | Induction: Remimazolam 12 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with successful anesthesia | Successful anesthesia was defined as no use of rescue sedative medication between start of the study medication and end of the surgical procedure completion of last skin suture. | Between the start of study medication and the end of the surgical procedure (up to approx 12 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Probst, MD | Heart Center Leipzig - University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herzzentrum Leipzig GmbH | Leipzig | 04289 | Germany |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| D000077149 | Sevoflurane |
| D000077208 | Remifentanil |
| D000074584 | WW Domain-Containing Oxidoreductase |
| D005283 | Fentanyl |
| D000077123 | Rocuronium |
| D012996 | Solutions |
| D007267 | Injections |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol |
| Drug |
|
|
| Sevoflurane | Drug |
|
|
| Remifentanil | Drug |
|
|
| Fentanyl | Drug |
|
|
| Rocuronium | Drug |
|
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000074583 | Short Chain Dehydrogenase-Reductases |
| D064430 | NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases |
| D000429 | Alcohol Oxidoreductases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |