drugset / Trial / NCT04125550

Propofol vs Sevoflurane in Cyanotic Congenital Heart Disease

NCT04125550 ↗

Phase 4 Completed 34 enrolled Cukurova University
RandomizedParallel-groupDouble-blindPrevention

Summary

The stress response to surgery compromises a series of humoral, metabolic, or cellular reactions. Cardiac surgery with use of cardiopulmonary bypass (CPB) is a major activator of the systemic inflammatory response (SIRS). Inflammation, resulting in neutrophil activation, plays a central role in the production of reactive oxygen species (ROS). Inflammatory and oxidative reactions may play a role in the more frequent observation of postoperative ventricular dysfunction in patients with cyanotic congenital heart disease (CHD) undergoing surgery. The aim of this study is to compare the anti-inflammatory and anti-oxidant effects of propofol and sevoflurane in children with cyanotic CHD undergoing open heart surgery with CPB.

Timeline

Start
2020-01-01
Primary completion
2021-11-01
Completion
2022-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Propofol Small molecule 10 mg/kg —
Comparator Sevoflurane Other / unclassified 2 % Inhaled