Measures to Lower the Stress Response in Pediatric Cardiac Surgery

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Ventricular septal defects
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Brief Title

Measures to Lower the Stress Response in Pediatric Cardiac Surgery

Official Title

Stress Response in Children Undergoing Cardiac Surgery: a Prospective Randomized Comparison Between Low Dose Fentanyl (LDF), Low Dose Fentanyl Plus Dexmedetomidine (LDF + Dex) and High Dose Fentanyl (HDF).

Brief Summary

      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.

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 (Dex) 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 (LDF), one will receive low dose fentanyl with dexmedetomidine (LDF
      + Dex), and one will receive high dose fentanyl (HDF). 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, adrenocorticotropic hormone (ACTH), Interleukin 8 (IL-8), TNF-alpha (Tumor
      Necrosis Factor), 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 Intensive Care Unit (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 Intelligence Quotient (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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

ACTH and Cytokine Levels

Secondary Outcome

 Stanford-Binet Cognitive Ability

Condition

Tetralogy of Fallot (TOF)

Intervention

Fentanyl (High Dose)

Study Arms / Comparison Groups

 Fentanyl (High Dose)
Description:  This arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. First half-dose given at induction and second half-dose given before incision.

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

52

Start Date

November 2008

Completion Date

December 2013

Primary Completion Date

December 2013

Eligibility 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:

          -  Patients who are having reoperation.

          -  Patients with comorbidities, such as heart failure.

          -  Patients receiving digoxin preoperatively.

Gender

All

Ages

1 Month - 3 Years

Accepts Healthy Volunteers

No

Contacts

Aymen N Naguib, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00848393

Organization ID

IRB08-00029

Secondary IDs

101911

Responsible Party

Principal Investigator

Study Sponsor

Nationwide Children's Hospital

Study Sponsor

Aymen N Naguib, MD, Principal Investigator, Nationwide Children's Hospital

Verification Date

July 2018