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Sponsored by: |
Nationwide Children's Hospital |
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Information provided by: | Nationwide Children's Hospital |
ClinicalTrials.gov Identifier: | NCT00848393 |
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 |
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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. |
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 |
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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.
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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.
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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
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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.
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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.
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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.
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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.
Ages Eligible for Study: | 1 Month to 1 Year |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aymen N Naguib, MD | 614-722-5625 | aymen.naguib@nationwidechildrens.org |
United States, Ohio | |
Nationwide Children's Hospital | Recruiting |
Columbus, Ohio, United States, 43205 | |
Principal Investigator: Aymen N Naguib, MD |
Principal Investigator: | Aymen N Naguib, MD | Nationwide Children's Hospital |
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 |
pediatric cardiac surgery stress response early extubation Dexmedetomidine |
TOF VSD AVSD |
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 |
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 |