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

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.

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Key information

Conditions

Cardiac Transplant Atrial Septal Defect Bidirectional Cavopulmonary Anastomosis Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Patent Ductus Arterious

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization

Other names: Precedex

Primary outcomes

Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine.

Time frame: Up to 24 hours following cardiac catheterization

Non-inferiority was shown when differences at steady-state (dexmedetomidine + sevoflurane) compared to baseline (sevoflurane alone) and its associated 95% confidence interval fell completely within the range of plus or minus 20%.The 95% confidence interval was normalized by subtracting the baseline values.

Bispectral Index: monitors electroencephalographic and electromyographic parameters to monitor the depth of anesthesia.

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Registry information

Official study title

The Pharmacology of Dexmedetomidine in Children With Congenital Heart Disease

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2011
First posted: May 31, 2007
Registry last updated: Jun 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed