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| Name | Class |
|---|---|
| Cairo University | OTHER |
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In pediatric patients ,undergoing elective surgical correction of aortic coarcatation one of our main concern is spinal cord protection .Our aim to study the protective effect of levosimendan versus its combination with magnesium sulphate .
Effect of levosimendan and its combination with magnesium sulphate infusion as spinal cord protection using NIRS values before Aortic cross clamp and 10,20 min after cross clamp till the end of surgery .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group C | Placebo Comparator | Control group will received saline |
|
| Group L | Active Comparator | Levosimendan group will received levosimendan infusion |
|
| Group M | Active Comparator | Levosimendan and Magnesium sulphate group will received both drugs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline Solution | Drug | Placebo |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Near Infrared Spectroscopy value | After aortic cross clamping to compare the spinal cord protective effect of levosimendan versus its combination with magnesium sulphate. | Perioperative(immediately before cross clamp,10&20 min after cross clamping Aorta) |
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Inclusion Criteria:
Age group ranging from 0 to 12 months of both sexes. Aortic coarcatation eligible for correction
Exclusion Criteria:
Parents or guardian refusal. Age more than12 months. Significant left ventricular dysfunction Patient with Heart block Patient with pre-existing CNS disorder eg seizure Patient with renal or hepatic dysfunction
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| Name | Affiliation | Role |
|---|---|---|
| Amel HY Abelala, professor | Cairo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sara ABD El-Salam | Cairo | 12555 | Egypt |
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| ID | Term |
|---|---|
| D001017 | Aortic Coarctation |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| D000077464 | Simendan |
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Levosimendan |
| Drug |
Levosimendan |
|
| Magnesium Sulfate | Drug | Magnesium Sulfate |
|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D006835 | Hydrazones |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D011724 | Pyridazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D017616 | Magnesium Compounds |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |