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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
160
continuous infusion of dexmedetomidine during the surgery
continuous infusion of normal saline during the surgery
Seoul national university hospital
Seoul, South Korea
RECRUITINGBayley 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)
Time frame: 1 year after the surgery
neurodevelopment biomarker
plasma glial fibrillary acidic protein concentration
Time frame: intraoperative (before skin incision, end of hypothermia, end of cardiopulmonary bypass), 4 hours after end of surgery
inflammation
level of IL-6
Time frame: 4 hours after end of surgery
acute kidney injury
urinary NGAL
Time frame: 2 hours after end of cardiopulmonary bypass
myocardial injury
level of Troponin i
Time frame: 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
Time frame: intraoperative (from anesthetic induction to end of surgery)
fluid management
amount of transfusion, ROTEM® values
Time frame: intraoperative (from anesthetic induction to end of surgery)
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fluid management
blood loss
Time frame: intraoperative (from anesthetic induction to end of surgery)