Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Patients with the diagnosis of AVSD and pulmonary hypertension
Patients less than 1 year and require any of the following repairs:
1. HLHS
2. Aortic arch reconstruction
3. Arterial switch
4. TOF with pulmonary atresia

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Normal saline as a placebo in addition to 15 µg/kg of fentanyl
Dexmedetomidine	Dexmedetomidine	Dexmedetomidine in addition to 15 µg/kg of fentanyl

Primary Outcome Measures

Name	Time	Method
Change in Hormone Levels	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	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	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 Outcome Measures

Name	Time	Method
Change in Bayley Language Composite Scores	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 Bayley Motor Composite Scores	From baseline to 1 year post-op	Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested 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.