Atrial Septal Defect Clinical Trial
Official title:
The Pharmacology 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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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