drugset / Trial / NCT05314569

Cardioprotective Effect of Ketamine-dexmeditomidine Versus Fentanyl-midazolam in Open Heart Surgery in Pediatrics

NCT05314569

Phase 1 Completed 81 enrolled Cairo University
RandomizedParallel-groupTriple-blindSupportive care

Summary

congenital hearts are very sensitive and irritable to deal with, especially during repair defects, the child's heart is exposed to impaired myocardial function during the entire procedure. Moreover, reperfusion of the heart during open-heart surgery when the myocardium is exposed to a global ischaemic cardioplegic arrest can induce myocardial injury. Myocardial reperfusion injury activates neutrophils, which trigger an inflammatory response resulting in the generation of reactive oxygen species (ROS), cytokine release, and complement activation, which further induce more cardiac injury. In addition to the inflammatory response generated as a result of tissue reperfusion injury, there is a significant systemic inflammatory response that is triggered by cardiopulmonary bypass (CPB) during open-heart surgery

Timeline

Start
2022-04-15
Primary completion
2022-09-20
Completion
2022-09-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 0.5 ug/kg
Comparator Fentanyl Other / unclassified 2 ug/kg
Comparator Isoflurane Other / unclassified
Comparator Ketamine Small molecule
Comparator Midazolam Small molecule 1 ug/kg

Indications

No indication recorded.