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The study is devoted to the use of ketamine infusion in a subanesthetic dose in the postoperative period in children after surgical correction of congenital heart defects in children.
The study will examine the safety and effectiveness for neuroprotection of subanesthetic doses of ketamine in the postoperative period in children undergoing operations to correct septal congenital heart defects using cardiopulmonary bypass.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine 1 | Experimental |
| |
| Ketamine 3 | Experimental |
| |
| Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine Hcl 50Mg/Ml Inj | Drug | ketamine infusion at a dose of 0.1 mg/kg/hour for 16 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers | monitoring the concentration of markers of brain damage at several control points | 16 hours after operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artem Ivkin | Recruiting | Kemerovo | Please Select | 650066 | Russia |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Ketamine Hcl 50Mg/Ml Inj |
| Drug |
ketamine infusion at a dose of 0.3 mg/kg/hour for 16 hours |
|
| Control | Other | Without ketamine |
|
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |