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| Sponsor: | Nationwide Children's Hospital |
|---|---|
| Information provided by: | Nationwide Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT00848393 |
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 |
|---|---|
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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. |
| 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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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.
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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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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
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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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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.
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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.
Other Name: Precedex for dexmedetomidine
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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.
Eligibility| Ages Eligible for Study: | 1 Month to 1 Year |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Aymen N Naguib MD Director Of Pediatric Cardiac 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: | February 19, 2009 |
| Health Authority: | United States: Food and Drug Administration |
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pediatric cardiac surgery stress response early extubation Dexmedetomidine |
TOF VSD AVSD |
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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 |
