Measures to Lower the Stress Response in Pediatric Cardiac Surgery
Information source: Nationwide Children's Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tetralogy of Fallot; Ventricular Septal Defects; Atrioventricular Septal Defects
Intervention: Fentanyl (Drug); Fentanyl (Drug); Dexmedetomidine and Fentanyl (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Nationwide Children's Hospital Official(s) and/or principal investigator(s):
Aymen N Naguib, MD, Principal Investigator, Affiliation: Nationwide Children's Hospital
Overall contact:
Aymen N Naguib, MD, Phone: 614-722-5625, Email: aymen.naguib@nationwidechildrens.org
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.
Clinical Details
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.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: The use of Dexmedetomidine in addition to low dose narcotic will lower the stress response as effective as the high dose narcotic.
Secondary outcome: The use of dexmedetomidine in addition to low dose narcotic will allow early extubation after pediatric cardiac surgery.
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
Minimum age: 1 Month.
Maximum age: 1 Year.
Gender(s): Both.
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.
Locations and Contacts
Aymen N Naguib, MD, Phone: 614-722-5625, Email: aymen.naguib@nationwidechildrens.org
Nationwide Children's Hospital, Columbus, Ohio 43205, United States; Recruiting
Aymen N Naguib, MD, Principal Investigator
Additional Information
Related publications: Mukhtar AM, Obayah EM, Hassona AM. The use of dexmedetomidine in pediatric cardiac surgery. Anesth Analg. 2006 Jul;103(1):52-6, table of contents. Mellon RD, Simone AF, Rappaport BA. Use of anesthetic agents in neonates and young children. Anesth Analg. 2007 Mar;104(3):509-20. Review. Anand KJ, Hickey PR. Halothane-morphine compared with high-dose sufentanil for anesthesia and postoperative analgesia in neonatal cardiac surgery. N Engl J Med. 1992 Jan 2;326(1):1-9. Anand KJ, Hansen DD, Hickey PR. Hormonal-metabolic stress responses in neonates undergoing cardiac surgery. Anesthesiology. 1990 Oct;73(4):661-70. Kapoor MC, Ramachandran TR. Inflammatory Response to Cardiac Surgery and Strategies to Overcome it. Ann Card Anaesth. 2004 Jul;7(2):113-28. Gruber EM, Laussen PC, Casta A, Zimmerman AA, Zurakowski D, Reid R, Odegard KC, Chakravorti S, Davis PJ, McGowan FX Jr, Hickey PR, Hansen DD. Stress response in infants undergoing cardiac surgery: a randomized study of fentanyl bolus, fentanyl infusion, and fentanyl-midazolam infusion. Anesth Analg. 2001 Apr;92(4):882-90.
Starting date: November 2008
Last updated: February 19, 2009
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