The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease

Completed · Phase 3

Conditions studied: Cardiac Transplant, Patent Ductus Arterious, Atrial Septal Defect, Bidirectional Cavopulmonary Anastomosis

In brief

The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and pharmacogenomics of dexmedetomidine in the following three pediatric patient populations: patients with bi-directional cavopulmonary anastomosis or a Fontan procedure, patients who have had a cardiac transplant, and patients with otherwise normal physiology who are undergoing closure of a patent ductus arteriosis or atrial septal defect.

Key facts

Study ID

NCT00480740

Run by

Children's National Research Institute

People needed

41

Starts

2006-12-01

Expected to finish

2011-10-01

Last updated by the study team

2015-06-26

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age is birth to 18 years
• > or = 6 kg.
• American Society of Anesthesiology (ASA) I, II, or III
• undergone prior cardiac transplant, Fontan or has a patent ductus arterious or atrial septal defect.
• scheduled for cardiac catheterization

You may not qualify if…

• subject or family history of malignant hyperthermia
• known hepatic disorder determined by history physical exam or laboratory tests
• pregnant or lactating female
• receiving inotropic agents or has a pacemaker
• weighs less than 6 kg.

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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