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

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Brief Title

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

Official Title

The Pharmacology of Dexmedetomidine in Children With Congenital Heart Disease

Brief 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.
    

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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


Condition

Cardiac Transplant

Intervention

Dexmedetomidine

Study Arms / Comparison Groups

 Cardiac Transplant
Description:  diagnostic cardiac catheterization in children with a transplanted heart

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

41

Start Date

December 2006

Completion Date

October 2011

Primary Completion Date

October 2011

Eligibility 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.
      

Gender

All

Ages

N/A - 18 Years

Accepts Healthy Volunteers

No

Contacts

Julia C Finkel, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00480740

Organization ID

IRB# 3908


Responsible Party

Principal Investigator

Study Sponsor

Children's National Research Institute


Study Sponsor

Julia C Finkel, MD, Principal Investigator, Children's National Research Institute


Verification Date

June 2015