NCT00576381

Understanding Dexmedetomidine in Neonates After Open Heart Surgery

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Athena Zuppa · Academic / Other
• Sex: All
• Age: 1 Hour – 30 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Tetrology of Fallot
• Heart Ventricle
• Hypoplastic Left Heart

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	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

Timeline

• Start date: 2006-04-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2007-12-19
• Last updated: 2013-04-18
• Results posted: 2013-04-11

Locations

1 site across 1 country: United States