Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study
NCT ID: NCT02492269
Last Updated: 2025-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2014-05-31
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Dexmedetomidine
Dexmedetomidine in addition to 15 µg/kg of fentanyl
Dexmedetomidine
Placebo
Normal saline as a placebo in addition to 15 µg/kg of fentanyl
Placebo
Interventions
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Dexmedetomidine
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. ASD
2. VSD
3. AVSD
4. TOF
5. Biventricular repair with left to right shunt.
Exclusion Criteria
* 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
1 Month
12 Months
ALL
No
Sponsors
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Aymen N Naguib
OTHER
Responsible Party
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Aymen N Naguib
Director of Pediatric Cardiothoracic Anesthesia
Locations
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Nationwide Children's Hospital
Columbus, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB13-00088
Identifier Type: -
Identifier Source: org_study_id
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