Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery (InfantDex)
This study is being conducted to determine what dexmedetomidine does to the body and in turn, what how the body handles the medication. This medication, for the purpose of this trial, is used as a short-term sedative for infants who are immediately post-operative from cardiac surgery and have a breathing tube and are breathing with the assistance of a mechanical ventilator or breathing machine.
Hypoplastic Left Heart
Tetralogy of Fallot
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Pharmacokinetics, Pharmacogenetics, and Pharmacodynamics of Dexmedetomidine In Infants Post-Operative From Cardiac Surgery|
- PK Profile of Dexmedetomidine [ Time Frame: after start of infusion (0.5, 1, 2, 4-6 hours), immediately prior to end of infusion and following end of infusion (0.25, 0.5, 1, 2, 4, 8, 12, 15-18 hours) ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2004|
|Study Completion Date:||October 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
Experimental: Dosing level
A predetermined dose of Dexmedetomidine
Dosage levels: Dose Level 1: Loading dose 0.35mcg/kg and CIVI 0.25mcg/kg/hr Dose Level 2: Loading Dose of 0.7mcg/kg and CIVI 0.5mcg/kg/hr and Dose Level 3: Loading Dose 1 mcg/kg and CIVI 0.75 mcg/kg/hr.
Other Name: Precedex
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.