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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julia Finkel, Children's Research Institute
ClinicalTrials.gov Identifier:
NCT00480740
First received: May 29, 2007
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Cardiac Transplant
Patent Ductus Arteriosus
Atrial Septal Defect
Bidirectional Cavopulmonary Anastomosis
Drug: Dexmedetomidine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Pharmacology of Dexmedetomidine in Children With Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Children's Research Institute:

Primary Outcome Measures:
  • Invasive and noninvasive hemodynamic parameters at baseline sevoflurane and during maintenance dosing on dexmedetomidine in patients with normal physiology, patients with Fontan physiology, and patients after cardiac transplant. [ Time Frame: Up to 24 hours following cardiac catheterization ] [ Designated as safety issue: Yes ]
  • The pharmacokinetics of dexmedetomidine in the pediatric population following escalating loading doses and continuous infusion at timed intervals will be estimated in patients with normal physiology, Fontan physiology, and cardiac transplant physiology. [ Time Frame: Up to 6 hours from the end of the dexmedetomidine continuous infusion ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: December 2006
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Dexmedetomidine
    Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization
    Other Name: Precedex
Detailed Description:

While opioid analgesia is currently the mainstream for management of pain in the perioperative setting, it often leads to significant morbidity, including opioid tolerance and hyperalgesia. Looking at ways to decrease the need for opioids with the use of adjunct medications allows for the long-term goal of decreasing physiologic tolerance in children. This is especially relevant in the pediatric congenital heart population.

Dexmedetomidine is in a class of drugs known as alpha-2 agonists and is known to provide analgesia, attenuate opioid tolerance and inhibit the sympathetic stress response. While there are numerous published case studies of dexmedetomidine validating its effectiveness and safety, the pharmacologic and pharmacodynamic profile has not been established.

This study will examine the hemodynamics, pharmacokinetics, and pharmacogenomics of dexmedetomidine in patients with congenital heart disease. The dose-ranging effect of dexmedetomidine will also be investigated. The three groups being studied will be: 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.

Comparison: Compare both invasive and noninvasive hemodynamic parameters at baseline sevoflurane and during maintenance dosing on dexmedetomidine. The pharmacokinetics of dexmedetomidine in the pediatric population following escalating loading doses and continuous infusion at timed intervals will be estimated. The efficacy of dexmedetomidine will be estimated by the amount of rescue doses of propofol that are given.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age is birth to 18 years
  • > or = 6 kg.
  • ASA I, II, or III
  • undergone prior cardiac transplant, Fontan or has a patent ductus arteriosus 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480740

Locations
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Children's Research Institute
Investigators
Principal Investigator: Julia C Finkel, MD Children's Research Institute
  More Information

Publications:
Responsible Party: Julia Finkel, MD, Children's Research Institute
ClinicalTrials.gov Identifier: NCT00480740     History of Changes
Other Study ID Numbers: IRB# 3908
Study First Received: May 29, 2007
Last Updated: May 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Research Institute:
Dexmedetomidine
Congenital heart disease
pharmacokinetics
pharmacodynamics
pediatric
Bidirectional cavopulmonary anastomosis
Fontan physiology
Cardiac transplant

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Diseases
Heart Septal Defects
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014