Measures to Lower the Stress Response in Pediatric Cardiac Surgery

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Aymen N Naguib, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT00848393
First received: February 19, 2009
Last updated: July 31, 2012
Last verified: July 2012
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 ]
  • Overall IQ score [ Time Frame: 1-4 yrs. post-surgery ] [ Designated as safety issue: No ]
    Overall IQ score from the assessment of cognitive ability, to determine if different anesthetic techniques during surgery for children with congenital heart disease result in differences in children's intellectual functioning.


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 ]
  • Cognitive factor scores [ Time Frame: 1-4 yrs post-surgery ] [ Designated as safety issue: No ]
  • Overall measure of developmental status [ Time Frame: 1-4 yrs post-surgery ] [ Designated as safety issue: No ]
  • A "total problems" score for emotional and behavioral adjustment. [ Time Frame: 1-4 yrs post-surgery ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: November 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High Dose Fentanyl
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.
Active Comparator: Low Dose Fentanyl
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.
Active Comparator: Low dose fentanyl plus Dexmedetomidine
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.
Other Name: Precedex for dexmedetomidine

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.

Children previously enrolled in the surgery study will complete assessments of their cognitive ability, developmental status, and emotional and behavioral adjustment. For the neuro-developmental outcome follow up, Children's cognitive ability will be assessed using the Stanford-Binet Intelligence Scales, 5th Edition (SB5). The SB5 is a widely-used measure of intellectual functioning that is normed for ages 2 and up. The test takes 30-50 minutes to administer to young children, and provides an overall IQ score, as well as scores for five primary factors of cognitive ability: Fluid Reasoning, Knowledge, Quantitative Reasoning, Visual-Spatial Processing; and Working Memory. The SB5 has demonstrated excellent reliability and validity.

  Eligibility

Ages Eligible for Study:   1 Month to 3 Years
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848393

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

Publications:
Responsible Party: Aymen N Naguib, Director of Pediatric Cardiothoracic Anesthesia, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00848393     History of Changes
Other Study ID Numbers: IRB08-00029, 101911
Study First Received: February 19, 2009
Last Updated: July 31, 2012
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

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Ventricular
Tetralogy of Fallot
Endocardial Cushion Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Fentanyl
Dexmedetomidine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on July 24, 2014