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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's National Research Institute; Children's Research Institute
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.