None listed
Conditions
Brief summary
Corrective surgery for congenital heart defects in children frequently requires cardiopulmonary bypass (CPB). The combination of anesthesia, surgical stress and CPB evokes an acute systemic inflammatory response with activation of cellular and humoral cascades. This response activates pathways that can lead to organ failure, which increases post-operative morbidity. The inflammatory response to CBP is often evaluated by means of inflammatory markers in the peripheral blood such as cytokines, acute phase proteins and white blood cells. The most important cytokines in relation to cardiac surgery are tissue necrosis factor 8 ( TNF 8), Interleukin(IL)-6, IL-8 and IL-10. Ketamine possesses several anti-inflammatory properties. It reduces neutrophil integrin expression and leucocyte-endothelial interaction and also inhibits monocyte and macrophage function. ketamine attenuates the in vitro synthesis of pro-inflammatory cytokines such as TNF8, Il-6 and IL-8 in the blood. In this study we will examine the effect of ketamine on the inflammatory response in pediatric patients undergoing on-pump cardiac surgery for congenital heart defects. We will also examine if this affects the need and the duration of inotropic drugs infusion and the length of ICU and hospital stay.
Interventions
In the first intervention group, anesthesia will be induced by Injection of intravenous Ketamine 1-2 mg/Kg, fentanyl 1-5 ug/Kg and rocuronium 0.5 mg/Kg then patient will be intubated and surgery will start.. Then anesthesia will be maintained by sevoflurane and additional doses of fentanyl and rocuronium as needed.
In the second intervention group, anesthesia will be also induced by Injection of intravenous Ketamine 1-2 mg/Kg, fentanyl 1-5 ug/Kg and rocuronium 0.5 mg/Kg and then Ketamine IV
In the first intervention group, anesthesia will be induced by Injection of intravenous Ketamine 1-2 mg/Kg, fentanyl 1-5 ug/Kg and rocuronium 0.5 mg/Kg then patient will be intubated and surgery will start.. Then anesthesia will be maintained by sevoflurane and additional doses of fentanyl and rocuronium as needed. In the second intervention group, anesthesia will be also induced by Injection of intravenous Ketamine 1-2 mg/Kg, fentanyl 1-5 ug/Kg and rocuronium 0.5 mg/Kg and then Ketamine IV infusion will start immediately after induction of general anesthesia and intubation at a dose 50 ug/Kg/min., and will continue till weaning off the patient from the cardiopulmonary bypass. ( so the exact duration is not fixed and it depends on the duration from induction of anesthesia till weaning off bypass), this will be in addition to sevoflurane and additional doses of fentanyl and rocuronium as needed. so the difference between the 2 intervention groups is administration of intravenous ketamine infusion during maintenance of anesthesia in the second intervention group.
Sponsors
Tamer Hamed Aly Ibrahim
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
1 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
All patients between one month and five years old undergoing on-pump cardiac surgeries for congenital heart diseases will be included.
Exclusion criteria
1- Patients with history of recent preoperative inflammation or infection. 2- patients with history of preoperative steroid therapy. 3- Patients undergoing cardiac surgery procedures requring total circulatory arrest.
Outcome results
None listed