Understanding Dexmedetomidine In Infants Post-Operative From Cardiac 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 infants who are immediately post-operative from cardiac surgery and require tracheal intubation with mechanical ventilation in the post-operative period. Three bolus doses and infusion doses will be administered to a total of 36 evaluable patients.

Inclusion criteria

• Patients must be greater or equal to one month or less than or equal to 24 months of age.
• Post operative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-op period.
• Planned tracheal extubation within 24 hours post-operatively.
• Adequate renal function(1-12 months old creatinine less than or equal to 0.6mg/dL and >12 months to 24 months creatinine < or= to 1.0mg/dL)
• Adequate liver function(Total bilirubin < or= 1.5mg/dL and ALT 1-12 months < or = to 165 U/L and > 12 months to 24 months < or = to 90 U/L)
• Isolated heart surgery
• Informed consent

Exclusion criteria

• Patients who have received another investigational drug within the past 30 days.
• Receiving continuous infusions of muscle relaxants in the postoperative setting.
• Patients whoo have a positive blood culture without a subsequent negative culture or other evidence of ongoing serious infection.
• Patients, who, int he opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
• Patients who show signs or symptoms of elevated intracranial pressure.
• Post-operative hypotension based on age.
• Preexisting bradycardia based on age.
• Heart block
• Weight < 5kg
• Patients, who in the opinion of the investigator, are not appropriate candidates for an investigational drug study.