Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480740
Status:
COMPLETED
Last Update Posted:
2015-06-26
First Post:
2007-05-29
Brief Title:
The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease
Sponsor:
Childrens National Research Institute
Organization:
Childrens National Research Institute
Study Overview
Official Title:
The Pharmacology of Dexmedetomidine in Children With Congenital Heart Disease
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None