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Neurodevelopmental disability is the most significant complication for survivors of infant surgery for congenital heart disease. In this study we sought to determine if intraoperative continuous infusion of dexmedetomidine are associated with neurodevelopmental outcomes at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental |
| |
| Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | continuous infusion of dexmedetomidine during the surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bayley scales of Infant development | Developmental outcomes at each assessment and within each domain (cognitive, language, and motor) were classified as "average" if they were within 1 SD of the mean or higher (scores .85), "at risk" if they were 1 to 2 SD below the mean (scores 70-84), and "delayed" if they were .2SD below the mean (,70). The trajectory of development over time in each domain (cognitive, language, and motor) | 1 year after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| neurodevelopment biomarker | plasma glial fibrillary acidic protein concentration | intraoperative (before skin incision, end of hypothermia, end of cardiopulmonary bypass), 4 hours after end of surgery |
| inflammation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eun-hee Kim | Contact | +82-01-9933-5014 | beloveun@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul national university hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35395776 | Derived | Ji SH, Kang P, Song IS, Jang YE, Lee JH, Kim JT, Kim HS, Kim EH. The effect of dexmedetomidine on neuroprotection in pediatric cardiac surgery patients: study protocol for a prospective randomized controlled trial. Trials. 2022 Apr 8;23(1):271. doi: 10.1186/s13063-022-06217-9. |
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| 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 |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Normal saline |
| Drug |
continuous infusion of normal saline during the surgery |
|
level of IL-6
| 4 hours after end of surgery |
| acute kidney injury | urinary NGAL | 2 hours after end of cardiopulmonary bypass |
| myocardial injury | level of Troponin i | intraoperative (before skin incision, end of cardiopulmonary bypass), 4 hours after end of surgery, 24 hours after end of surgery |
| anesthesia monitoring | Bispectral index, end tidal sevoflurane | intraoperative (from anesthetic induction to end of surgery) |
| fluid management | amount of transfusion, ROTEMĀ® values | intraoperative (from anesthetic induction to end of surgery) |
| fluid management | blood loss | intraoperative (from anesthetic induction to end of surgery) |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |