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

Study 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.

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with the following diagnosis: ASD VSD AVSD TOF 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: HLHS Aortic arch reconstruction Arterial switch TOF with pulmonary atresia

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>Dexmedetomidine in addition to 15 µg/kg of fentanyl | Drug: Dexmedetomidine<br> <br> * Other names: Precedex;|
| Placebo Comparator: Placebo<br>Normal saline as a placebo in addition to 15 µg/kg of fentanyl | Drug: Placebo<br> <br> * Other names: normal saline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cytokine levels | Cytokine levels in plasma and MUF 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. | From baseline to 24 hrs post-op | 
| Change in hormone levels | 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. | From baseline to 24 hrs post-op | 
| Change in neurodevelopmental scores | 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. | From baseline to 1 year post-op |