Measures to Lower the Stress Response in Pediatric Cardiac Surgery
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Psychiatric |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any - 3 |
| Updated: | 7/29/2018 |
| Start Date: | November 2008 |
| End Date: | December 2013 |
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).
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.
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.
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.
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.
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.
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