Understanding Dexmedetomidine in Neonates After Open Heart Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Neonates Following Open Heart Surgery

Conditions
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Tetrology of Fallot, Heart Ventricle, Hypoplastic Left Heart

Intervention / Treatment
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* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery. | Drug: Dexmedetomidine<br>* Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion<br>* Other names: Precedex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK Profile of Dexmedetomidine | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Precedex, Open Heart Surgery, Dexmedetomidine, Sedation