Dexmedetomidine Neuroprotection in Pediatric Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Neurodevelopmental disability is the most significant complication for survivors of infant surgery for congenital heart disease. In this study we sought to determine if intraoperative continuous infusion of dexmedetomidine are associated with neurodevelopmental outcomes at 12 months.

Official Title
-----------------
The Effect of Dexmedetomidine on Neuroprotection in Pediatric Cardiac Surgery Patients: a Randomized Controlled Trial

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

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates undergoing cardiac surgery Infants undergoing cardiac surgery with cardiopulmonary bypass (atrial septal defect repair, ventricular septal defect repair, or tetralogy of fallot repair) Exclusion Criteria: History of hypersensitivity of any drug Presence of hypotension or bradycardia considering age Bradycardia (heart rate < 80 beats/min) or hypotension (systolic blood pressure < 70mmHg for infants, < 60mmHg for neonates) Elevated liver enzyme levels (aspartate transaminase >100unit/L, alanine aminostrasferase > 50 unit/L) surgery with deep hypothermic circulatory arrest Presence of complex cardiac defect single ventricular physiology plan of additional operation within a year preoperative use of beta-agonists presence of history of any neurological disorder

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br> | Drug: Dexmedetomidine<br>* continuous infusion of dexmedetomidine during the surgery<br>|
| Placebo Comparator: Control<br> | Drug: Normal saline<br>* continuous infusion of normal saline during the surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bayley scales of Infant development | Developmental outcomes at each assessment and within each domain (cognitive, language, and motor) were classified as average if they were within 1 SD of the mean or higher (scores .85), at risk if they were 1 to 2 SD below the mean (scores 70-84), and delayed if they were .2SD below the mean (,70). The trajectory of development over time in each domain (cognitive, language, and motor) | 1 year after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurodevelopment biomarker | plasma glial fibrillary acidic protein concentration | intraoperative (before skin incision, end of hypothermia, end of cardiopulmonary bypass), 4 hours after end of surgery | 
| inflammation | level of IL-6 | 4 hours after end of surgery | 
| acute kidney injury | urinary NGAL | 2 hours after end of cardiopulmonary bypass | 
| myocardial injury | level of Troponin i | intraoperative (before skin incision, end of cardiopulmonary bypass), 4 hours after end of surgery, 24 hours after end of surgery | 
| anesthesia monitoring | Bispectral index, end tidal sevoflurane | intraoperative (from anesthetic induction to end of surgery) | 
| fluid management | amount of transfusion, ROTEM® values | intraoperative (from anesthetic induction to end of surgery) | 
| fluid management | blood loss | intraoperative (from anesthetic induction to end of surgery) |