Hypoplastic Left Heart Clinical Trial
Official title:
The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Neonates Following Open Heart Surgery
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.
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.
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Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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