Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00480740
Study type Interventional
Source Children's Research Institute
Contact
Status Completed
Phase Phase 3
Start date December 2006
Completion date October 2011

See also
  Status Clinical Trial Phase
Completed NCT01120964 - Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol Phase 1/Phase 2
Active, not recruiting NCT04950192 - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Completed NCT02621528 - Lifetech CeraFlex™ Post-Market Surveillance Study N/A
Recruiting NCT04291898 - Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study N/A
Terminated NCT01773252 - Right to Left Cardiac Shunt Detection Phase 3
Not yet recruiting NCT06344494 - Cardiac Interventional ICE Imaging Trial N/A
Not yet recruiting NCT05887700 - Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
Recruiting NCT06431178 - General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients N/A
Recruiting NCT06298344 - The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease Early Phase 1
Active, not recruiting NCT04105595 - Post Market Registry of the CBSO
Recruiting NCT05688670 - Regional Anesthesia Following Pediatric Cardiac Surgery Phase 4
Active, not recruiting NCT02739087 - Radiation-Free Heart Catheterization Using MRI N/A
Recruiting NCT02097758 - Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect N/A
Completed NCT02985684 - Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs N/A
Completed NCT06139679 - Improvement In Left Ventricular Diameter After Closure Of ASD With Fenestrated Patch: A Cross-sectional Study
Recruiting NCT05540769 - Holter and ECG Changes After Transcatheter Closure Of ASD In Children N/A
Recruiting NCT04096924 - A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions N/A
Enrolling by invitation NCT02766569 - International Registry for ASD Closure by Using the Occlutech®Flex II Device in More Than 2000 Patients N/A
Completed NCT02957201 - The Effect on EPCs by Successful Cardiac Occlusion Device Implantation N/A
Recruiting NCT02453451 - The Effect of the Hole in the Cardiac Septum Developed by the MitraClip Procedure on the Blood Flow Mechanics N/A