A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics

Inclusion Criteria:

• Male or female, age 0 to 180 days at the time of surgery.
• Diagnosis of: D-transposition of the great arteries (with or without ventricular septal defect), or tetralogy of Fallot, or ventricular septal defect (with or without associated atrial septal defect and/or patent ductus arteriosus)
• Scheduled for complete corrective two-ventricle surgical repair with cardiopulmonary bypass.

Exclusion Criteria:

• Less than 37 completed weeks' gestational age at birth.
• Enrollment in the PHN Collaborative Learning Study, if tetralogy of Fallot 91-180 days of age only.
• Known or suspected hepatic dysfunction; AST and ALT >3X upper limit of normal at the time of screening within 72 hours of operation.
• Known or suspected renal dysfunction; serum creatinine > 0.8 mg/dL within 72 hours of operation.
• Preoperative administration of DEX or clonidine within 72 hours of operation.
• Major congenital anomaly(ies) outside the cardiovascular system.
• Preoperative central nervous system injury resulting in clinical signs and symptoms: coma, seizures, hemiparesis.
• Planned period of deep hypothermic circulatory arrest.
• History of second or third degree heart block.
• Sinus or junctional bradycardia below 80 BPM sustained for greater than 15 minutes within 72 hours of operation.
• Junctional rhythm sustained for greater than 15 minutes within 72 hours of operation.
• Hypotension defined as mean arterial blood pressure below 35 mm Hg for 0-21 day old neonatal patients, and below 40 mm Hg for 22- 180 day old infant patients sustained for greater than 15 minutes within 72 hours of operation.
• History of cardiac arrest or ECMO cannulation.