Congenital Heart Disease
Conditions
Brief summary
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.
Interventions
DRUGDexmedetomidine
continuous infusion of dexmedetomidine during the surgery
DRUGNormal saline
continuous infusion of normal saline during the surgery
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
Inclusion criteria
* Neonates undergoing cardiac surgery * Infants undergoing cardiac surgery with cardiopulmonary bypass (atrial septal defect repair, ventricular septal defect repair, or tetralogy of fallot repair)
Exclusion criteria
* History of hypersensitivity of any drug * Presence of hypotension or bradycardia considering age Bradycardia (heart rate \< 80 beats/min) or hypotension (systolic blood pressure \< 70mmHg for infants, \< 60mmHg for neonates) * Elevated liver enzyme levels (aspartate transaminase \>100unit/L, alanine aminostrasferase \> 50 unit/L) * surgery with deep hypothermic circulatory arrest * Presence of complex cardiac defect * single ventricular physiology * plan of additional operation within a year * preoperative use of beta-agonists * presence of history of any neurological disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bayley scales of Infant development | 1 year after the surgery | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| inflammation | 4 hours after end of surgery | level of IL-6 |
| acute kidney injury | 2 hours after end of cardiopulmonary bypass | urinary NGAL |
| neurodevelopment biomarker | intraoperative (before skin incision, end of hypothermia, end of cardiopulmonary bypass), 4 hours after end of surgery | plasma glial fibrillary acidic protein concentration |
| anesthesia monitoring | intraoperative (from anesthetic induction to end of surgery) | Bispectral index, end tidal sevoflurane |
| fluid management | intraoperative (from anesthetic induction to end of surgery) | amount of transfusion, ROTEM® values |
| myocardial injury | intraoperative (before skin incision, end of cardiopulmonary bypass), 4 hours after end of surgery, 24 hours after end of surgery | level of Troponin i |
Countries
South Korea
Contacts
Primary ContactEun-hee Kim
Outcome results
None listed