CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Dexmedetomidine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02492269
NCT02492269Phase 2Completed

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

Aymen N Naguib·interventional·Posted Jul 8, 2015·Updated Aug 7, 2025

In Brief

A Phase 2 clinical trial evaluating Dexmedetomidine and Placebo for Congenital Heart Disease. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 8, 2015
Enrollment StartMay 1, 2014
Primary CompletionDec 1, 2024
TodayJul 2, 2026
Enrollment to primary: 10.6 yearsPosted 11.0 years ago

Interventions

Dexmedetomidinedrug

Placebodrug