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

Aymen N Naguib

Status and phase: Completed; Phase 2

Conditions: Congenital Heart Disease

Treatments: Drug: Dexmedetomidine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02492269

IRB13-00088

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 1 to 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with the following diagnosis:

  1. ASD
  2. VSD
  3. AVSD
  4. TOF
  5. 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:

  1. HLHS
  2. Aortic arch reconstruction
  3. Arterial switch
  4. TOF with pulmonary atresia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Dexmedetomidine

Experimental group

Description:

Dexmedetomidine in addition to 15 µg/kg of fentanyl

Treatment:

Drug: Dexmedetomidine

Placebo

Placebo Comparator group

Description:

Normal saline as a placebo in addition to 15 µg/kg of fentanyl

Treatment:

Drug: Placebo