NCT02492269

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Aymen N Naguib · Academic / Other
• Sex: All
• Age: 1 Month – 12 Months
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Dexmedetomidine
DRUG	Placebo

Timeline

• Start date: 2014-05-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2015-07-08
• Last updated: 2025-08-07
• Results posted: 2025-08-07

Locations

1 site across 1 country: United States