Understanding Dexmedetomidine in Neonates After Open Heart Surgery

Phase 1

Completed

Brief Summary: The purpose of this study is to determine what happens to dexmedetomidine in the body after it has been given to a newborn after heart surgery. We want to learn how long the drug stays in the body, how the drug is metabolized by the body, and how well the medicine works at a particular dose or amount.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
A	Dexmedetomidine	Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery.

Primary Outcome Measures

Name	Time	Method
PK Profile of Dexmedetomidine	A sparse PK sampling method was utilized. Between 6-12 PK samples were drawn : After start of infusion (0.5, 4-6, 8 hours), immediately prior to end of infusion and following end of infusion (0.25, 0.5, 1, 2-4, 6-8, 10-12 & 18hrs)	This study measured the concentration of dex in the body and used those concentrations to determine how quickly the body metabolizes and eliminates dex(concentration-time or pharmacokinetic profile).The concentration of dex in the body is determined through serial blood sampling while administering dex and following discontinuation.

Secondary Outcome Measures