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During repair of a congenital heart defect the child is exposed to myocardial hypoxia. Recent studies have suggested that the paediatric myocardium is more sensitive to hypoxia and cardioplegic arrest than the adult. The protective effect of halogenated agents on ischaemia and reperfusion injury has been investigated widely in adults. The investigators hypothesis that sevoflurane applied during cardiopulmonary bypass might afford better myocardial protection during paediatric cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevoflurane | Experimental | Patients will receive 2% sevoflurane via oxygenator during CPB |
|
| Control | No Intervention | Patients will receive only oxygen and air through oxygenator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane | Drug | Sevoflurane will be given at a concentration of 2% through oxygenator during CPB |
|
| Measure | Description | Time Frame |
|---|---|---|
| all cause mortality | All cause mortality after the cardaic surgery, patients will be followed up for 30 days | within the first 30 days (plus or minus 3 days) after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| serum cTnI concentrations | serial serum cTnI concentrations will be determined to whether sevoflurane application during CPB will decrease the cTnI release after operation. | 48 h after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenxiao Jin, Ph.D | Contact | 86-29-84771022 | jinzx10262@yahoo.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhenxiao Jin, PhD | Department of Cardiovascular Surgery, Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiovascular Surgery, Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26418205 | Derived | Xiong HY, Liu Y, Shu DC, Zhang SL, Qian X, Duan WX, Cheng L, Yu SQ, Jin ZX. Effects of Sevoflurane Inhalation During Cardiopulmonary Bypass on Pediatric Patients: A Randomized Controlled Clinical Trial. ASAIO J. 2016 Jan-Feb;62(1):63-8. doi: 10.1097/MAT.0000000000000285. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 19, 2013 | |
| Reset | Jan 7, 2014 | |
| Release | Aug 18, 2014 | |
| Reset | Aug 19, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 19, 2013 | Jan 7, 2014 | |||
| Aug 18, 2014 |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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| Control | Other | Patients will receive only oxygen and air through oxygenator |
|
| Aug 19, 2014 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |