Understanding Dexmedetomidine in Neonates After Open Heart Surgery

This is a single center, dose escalation study of a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours in neonates who are immediately post-op from cardiac surgery, and require tracheal intubation with mechanical ventilation in the post-op period.

Pediatric populations may benefit from the favorable pharmacodynamic effects of this medication.

Inclusion criteria

• Patients must be less than or equal to 1 month old.
• Postconceptual age must be > or equal to 37 weeks on the day of surgery.
• Postoperative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-op period.
• Planned tracheal extubation within 24 hrs post-op.
• Adequate renal function (serum creatine < or equal to 1.5mg/dL)
• Adequate liver function (ALT < or equal to 165 U/L)
• Isolated heart surgery
• Informed consent

Exclusion criteria

• Patients who have received another investigational drug since birth.
• Patients receiving continuous infusions of muscle relaxants in the post-op setting.
• Pateints who have a positive blood culture without a subsequent negative culture of other evidence of ongoing serious infection.
• Patients who show signs and symptoms of elevated intracranial pressure.
• Post-op hypotension defined by post conceptual age.
• Pre-existing bradycardia defined by age
• Heart block
• Weight < 2kg
• Patients who, in the opinion of the investigator, are not appropriate candidates for an investigational drug study