Cardiac Surgical Procedures
Conditions
Keywords
Dexmedetomidine, Congenital Heart Disease, Cardiopulmonary Bypass, Interleukin
Brief summary
Cardiopulmonary bypass-assisted surgery initiates a systemic inflammatory response induced by extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit, endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation, ischemia-reperfusion injury of myocardium) factors. This may either be mild or lead to a more severe clinical condition. Inflammation after pediatric open heart surgery is a parameter affecting also duration of mechanical ventilatory support. Dexmedetomidine use was associated with a reduced increase in plasma IL-1, IL-6, TNF-a, and INF-g levels
Detailed description
Dexmedetomidine will be used during Cardiopulmonary bypass-assisted surgery for pediatric cardiac surgery
Interventions
DRUGDexmedetomidine
Dexmedetomidine 0.5 mcg/kg diluted with normal saline in Dexmedetomidine group. Second syringe (50 ml) will contain normal saline (0.9%) in addition to Dexmedetomidine in addition to normal saline in Dexmedetomidine group. Concentration of Dexmedetomidine will be diluted according to the body weight so that we will fix the rate of infusion (1 ml/kg) to achieve a concentration of 0.5 mcg/kg/h in Dexmedetomidine group.
DRUGNormal saline
One syringe contain normal saline in 5 ml in Saline group. Second syringe (50 ml) will contain normal saline (0.9%) alone in rate of infusion (1 ml/kg) in Saline group
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Elective repair of congenital heart disease with cardiopulmonary bypass Exclusion Reintervention surgery requirement for blood products from the start of CPB, preoperative intake of corticosteroids, deep hypothermia, those with preoperative low cardiac output, those with non-palpable peripheral pulses before surgery (e.g., accompanying coarctation of the aorta) or ischemic time during cardiopulmonary bypass more than 90 minutes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infilamatory response | Within the first 24 hours | Interleukin 6 and 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation score | Within the first 24 hours | Special scale |
| Length of mechanical ventilaton | Within 7 days | Length of mechanical ventilaton In days |
| Length of ICU stay | Within 7 days | Length of ICU stay In days |
| Length of hospital stay. | Within 7 days | Length of hospital stay days |
Countries
Egypt
Contacts
Primary ContactSayed K Abd-Elshafy, MD
Outcome results
None listed