Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial.

Autor: Cardoso TAAM; Department of Surgery and Anesthesia, Dante Pazzanese Institute of Cardiology, Captain Pinto Ferreira Street, 62, ap 92, Jardim Paulista, São Paulo, 01423-020, Brazil. thiago-ma@hotmail.com., Kunst G; Department of Anaesthetics, Intensive Care Medicine and Pain Therapy, King's College Hospital NHS Foundation Trust, Denmark Hill, London, UK., Neto CN; Department of Surgery and Anesthesia, Dante Pazzanese Institute of Cardiology, Captain Pinto Ferreira Street, 62, ap 92, Jardim Paulista, São Paulo, 01423-020, Brazil., de Ribamar Costa Júnior J; Department of Interventional Cardiology, Dante Pazzanese Institute of Cardiology, São Paulo, Brazil., Silva CGS; Department of Surgery and Anesthesia, Dante Pazzanese Institute of Cardiology, Captain Pinto Ferreira Street, 62, ap 92, Jardim Paulista, São Paulo, 01423-020, Brazil., Bastos GM; Molecular Cardiology Research Laboratory, Dante Pazzanese Institute of Cardiology, São Paulo, Brazil., Borges JB; Molecular Cardiology Research Laboratory, Dante Pazzanese Institute of Cardiology, São Paulo, Brazil., Hirata MH; Department of Clinical and Toxicological Analysis, School of Pharmaceutical Sciences, University of São Paulo, São Paulo, Brazil.
Jazyk: angličtina
Zdroj: Trials [Trials] 2021 Jan 06; Vol. 22 (1), pp. 25. Date of Electronic Publication: 2021 Jan 06.
DOI: 10.1186/s13063-020-04809-x
Abstrakt: Background: Recent 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.
Methods: We 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.
Discussion: The trial may determine whether adding volatile anesthetic during cardiopulmonary bypass will attenuate the inflammatory response.
Trial Registration: ClinicalTrials.gov NCT02672345 . Registered on February 2016 and updated on June 2020.
Databáze: MEDLINE
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