At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
Dexmedetomidinedrug
Likely dose
Dexmedetomidine 0.25mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Neonates Following Open Heart Surgery
In Brief
A Phase 1 clinical trial evaluating Dexmedetomidine for Tetrology of Fallot and 2 related conditions. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTetrology of Fallot, Heart Ventricle, Hypoplastic Left Heart
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2006
First PostedDec 2007
Primary CompletionDec 2010
TodayJul 2026
First PostedDec 19, 2007
Enrollment StartApr 1, 2006
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 18.5 years ago
Interventions
Dexmedetomidinedrug
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