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Measures to Lower the Stress Response in Pediatric Cardiac Surgery
This study is currently recruiting participants.
Verified by Nationwide Children's Hospital, February 2009
First Received: February 19, 2009   No Changes Posted
Sponsored by: Nationwide Children's Hospital
Information provided by: Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00848393
  Purpose

Cardiac surgery induces a measurable stress response in patients which leads to increased morbidity and mortality post-operatively. Through clinical observation, anesthesiologists have determined that varying the combinations of anesthesia drugs used during surgery and just after reduces the stress response, and by extension, morbidity and mortality. However, only a few studies have explored this phenomenon scientifically.


Condition Intervention
Tetralogy of Fallot
Ventricular Septal Defects
Atrioventricular Septal Defects
Drug: Fentanyl
Drug: Dexmedetomidine and Fentanyl

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: Stress Response in Children Undergoing Cardiac Surgery: a Prospective Randomized Comparison Between Low Dose Fentanyl, Low Dose Fentanyl Plus Dexmedetomidine and High Dose Fentanyl.

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • The use of Dexmedetomidine in addition to low dose narcotic will lower the stress response as effective as the high dose narcotic. [ Time Frame: stress hormones and cytokines levels will be measured at the following points; after induction, after sternotomy, after starting cardiopulmonary bypass, at the end of the procedure and 24 hours after the procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The use of dexmedetomidine in addition to low dose narcotic will allow early extubation after pediatric cardiac surgery. [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: November 2008
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
High Dose Fentanyl: Active Comparator
patients in this arm will receive a total of 25 mcg/kg of fentanyl in two divided doses. first half will be given at induction and the second half will be given before incision.
Drug: Fentanyl
25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision.
Low Dose Fentanyl: Active Comparator
patients in this group will receive a total of 10mcg/kg of fentanyl. half the dose will be given at induction and the second half will be given before incision
Drug: Fentanyl
patients will receive a total of 10mcg/kg of fentanyl. half the dose will be given at induction and the second half before incision.
Low dose fentanyl plus Dexmedetomidine: Active Comparator
patients in this group will receive a total of 10mcg/kg of fentanyl in two divided doses and Dexmedetomidine at a loading dose of 1mcg/kg over 10 minutes and then an infusion of Dexmedetomidine at 0.5mcg/kg/hr.
Drug: Dexmedetomidine and Fentanyl
Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr.in addition this group will receive a total of 10 mcg/kg fentanyl. Half the dose will be given at induction and the second half before incision.

Detailed Description:

In this study, we aim to demonstrate comparatively that use of dexmedetomidine in addition to low dose narcotics reduces the stress response in cardiac surgical patients and results in less morbidity and mortality.

Additionally, dexmedetomidine should facilitate safe early extubation in pediatric cardiac patients, which results in decreased ventilator associated co-morbidities. Patients will be randomly assigned to three groups; one group will receive low dose fentanyl, one will receive low dose fentanyl with dexmedetomidine, and one will receive high dose fentanyl. Blood samples will be collected post-induction, post-sternotomy, after going on cardiopulmonary bypass, at the completion of surgery, and post-operatively to determine the patients' stress hormone levels. The patients will receive standard post-operative care, and clinical data collected as part of this care will be used to determine the incidence of morbidity and mortality. The results of the blood tests will be correlated with the incidence of morbidity and mortality to demonstrate the relative effectiveness of the different anesthesia methods. Blood samples will be analyzed for the presence of the stress hormones cortisol, epinephrine, norepinephrine, ACTH, Interleukin 8, TNF-alpha, and nitrated albumin. Arterial blood gas, glucose and lactate levels, heart rate, blood pressure, use of vasoactive support, length of ventilator use, post-operative mortality, post-operative morbidity, length of ICU stay, and length of hospital stay will be recorded.

  Eligibility

Ages Eligible for Study:   1 Month to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Childrens with the diagnosis of tetralogy of fallot, ventricular septal defect and atrioventricular septal defect who are under one year of age.

Exclusion Criteria:

  • Patient who are having reoperation.
  • Patients with comorbidities, such as heart failure.
  • Patients receiving digoxin preoperatively.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848393

Contacts
Contact: Aymen N Naguib, MD 614-722-5625 aymen.naguib@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Principal Investigator: Aymen N Naguib, MD            
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Aymen N Naguib, MD Nationwide Children's Hospital
  More Information

Publications:
Responsible Party: Nationwide Children's Hospital ( Aymen N Naguib MD Director Of Pediatric Cardiac Anesthesia )
Study ID Numbers: IRB08-00029, 101911
Study First Received: February 19, 2009
Last Updated: February 19, 2009
ClinicalTrials.gov Identifier: NCT00848393     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Nationwide Children's Hospital:
pediatric cardiac surgery
stress response
early extubation
Dexmedetomidine
TOF
VSD
AVSD

Study placed in the following topic categories:
Neurotransmitter Agents
Fentanyl
Adrenergic Agents
Anesthetics
Endocardial Cushion Defects
Adrenergic Agonists
Heart Septal Defects, Ventricular
Hypnotics and Sedatives
Dexmedetomidine
Analgesics
Congenital Abnormalities
Analgesics, Opioid
Anesthetics, Intravenous
Heart Septal Defects
Adrenergic alpha-Agonists
Heart Diseases
Cardiovascular Abnormalities
Adjuvants, Immunologic
Stress
Central Nervous System Depressants
Narcotics
Fallot Tetralogy
Analgesics, Non-Narcotic
Anesthetics, General
Tetralogy of Fallot
Atrioventricular Septal Defect
Ventricular Septal Defects
Congenital Heart Septum Defect
Peripheral Nervous System Agents
Heart Defects, Congenital

Additional relevant MeSH terms:
Neurotransmitter Agents
Fentanyl
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Anesthetics
Endocardial Cushion Defects
Adrenergic Agonists
Sensory System Agents
Heart Septal Defects, Ventricular
Therapeutic Uses
Hypnotics and Sedatives
Cardiovascular Diseases
Dexmedetomidine
Analgesics
Congenital Abnormalities
Analgesics, Opioid
Anesthetics, Intravenous
Heart Septal Defects
Adrenergic alpha-Agonists
Heart Diseases
Cardiovascular Abnormalities
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia
Analgesics, Non-Narcotic
Anesthetics, General
Tetralogy of Fallot
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 30, 2009