Abstract
BackgroundRecent experimental evidence shows that sevoflurane can reduce the inflammatory response during cardiac surgery with cardiopulmonary bypass. However, this observation so far has not been assessed in an adequately powered randomized controlled trial.MethodsWe plan to include one hundred patients undergoing elective coronary artery bypass graft with cardiopulmonary bypass who will be randomized to receive either volatile anesthetics during cardiopulmonary bypass or total intravenous anesthesia. The primary endpoint of the study is to assess the inflammatory response during cardiopulmonary bypass by measuring PMN-elastase serum levels. Secondary endpoints include serum levels of other pro-inflammatory markers (IL-1β, IL-6, IL-8, TNFα), anti-inflammatory cytokines (TGFβ and IL-10), and microRNA expression in peripheral blood to achieve possible epigenetic mechanisms in this process. In addition clinical endpoints such as presence of major complications in the postoperative period and length of hospital and intensive care unit stay will be assessed.DiscussionThe trial may determine whether adding volatile anesthetic during cardiopulmonary bypass will attenuate the inflammatory response.Trial registrationClinicalTrials.gov NCT02672345. Registered on February 2016 and updated on June 2020.
Highlights
Since 1953, when Gibbon performed the first successful human intracardiac operation using a mechanical extracorporeal pump oxygenator [1], cardiac surgery with cardiopulmonary bypass (CPB) has been transformed into a relatively standardized medical procedure, performed on millions of patients around the world.Despite major improvements during the last decades, CPB continues to be associated with an undesirable inflammatory reaction affecting the brain, kidneys, liver, lungs, and heart
Sample size The sample size is based on the calculations performed from the data provided by the authors of an experimental article [2] whose difference in nanograms per milliliter is greater than 50% between the means of the groups that used or not the volatile anesthetic sevoflurane during the longest CPB applied by those authors (90 min) with a standard deviation (SD) of 30.71, a significance level of 5%, and a power of the sample of 80% generated from 100 patients causing a significant reduction in plasma PMNelastase levels in the group that included sevoflurane in the gas circuit
PMN-elastase is contained in polymorphonuclear granules and is released early, accounting for extracellular immune defense after exposure to the CPB circuit with a peak concentration within 90 min in vitro [2]
Summary
Despite major improvements during the last decades, CPB continues to be associated with an undesirable inflammatory reaction affecting the brain, kidneys, liver, lungs, and heart. These inflammatory reactions are the result of contact of patients’ blood with the nonbiocompatible circuit of the CPB machine. Recent experimental evidence shows that sevoflurane can reduce the inflammatory response during cardiac surgery with cardiopulmonary bypass. This observation so far has not been assessed in an adequately powered randomized controlled trial
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