Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study
Overview
- Phase
- Phase 2
- Intervention
- Dexmedetomidine
- Conditions
- Congenital Heart Disease
- Sponsor
- Aymen N Naguib
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in Hormone Levels
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
The overall goal of this project is to determine the role of anesthetic management in children undergoing cardiac surgery utilizing CPB in the setting of fast tracking and early extubation. An ideal anesthetic technique would ensure abolishing or diminishing stress response as would be evident by the stress markers levels and the level of two cerebral injury biomarkers (S 100 B and NSE). This should translate to better immediate postoperative outcome and hopefully improve both the short and the long term neurodevelopmental outcome in these children. The project is prospective, randomized and blinded study. The first and second aim of the study should be conducted over 2 year period. Our long term aim will be concluded when these children reach the school age.
Investigators
Aymen N Naguib
Director of Pediatric Cardiothoracic Anesthesia
Nationwide Children's Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients with the following diagnosis:
- •Biventricular repair with left to right shunt.
Exclusion Criteria
- •Patients with the diagnosis of AVSD and pulmonary hypertension
- •Patients less than 1 year and require any of the following repairs:
- •Aortic arch reconstruction
- •Arterial switch
- •TOF with pulmonary atresia
Arms & Interventions
Dexmedetomidine
Dexmedetomidine in addition to 15 µg/kg of fentanyl
Intervention: Dexmedetomidine
Placebo
Normal saline as a placebo in addition to 15 µg/kg of fentanyl
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Hormone Levels
Time Frame: From baseline to 24 hrs post-op
ACTH, cortisol, epinephrine, \& norepinephrine will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively.
Change in Bayley Cognitive Composite Scores
Time Frame: From baseline to 1 year post-op
Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested prior to discharge from the hospital, at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress. Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment.
Change in Cytokine Levels
Time Frame: From baseline to 24 hrs post-op
Cytokine levels in plasma samples will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively.
Secondary Outcomes
- Change in Bayley Language Composite Scores(From baseline to 1 year post-op)
- Change in Bayley Motor Composite Scores(From baseline to 1 year post-op)