Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial
Abstract 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...
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doaj-400b319d2f2c48a4ae6527b3adbb30e82021-01-10T12:45:00ZengBMCTrials1745-62152021-01-0122111010.1186/s13063-020-04809-xEffect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trialThiago Augusto Azevedo Maranhão Cardoso0Gudrun Kunst1Caetano Nigro Neto2José de Ribamar Costa Júnior3Carlos Gustavo Santos Silva4Gisele Medeiros Bastos5Jéssica Bassani Borges6Mario Hiroyuki Hirata7Department of Surgery and Anesthesia, Dante Pazzanese Institute of CardiologyDepartment of Anaesthetics, Intensive Care Medicine and Pain Therapy, King’s College Hospital NHS Foundation TrustDepartment of Surgery and Anesthesia, Dante Pazzanese Institute of CardiologyDepartment of Interventional Cardiology, Dante Pazzanese Institute of CardiologyDepartment of Surgery and Anesthesia, Dante Pazzanese Institute of CardiologyMolecular Cardiology Research Laboratory, Dante Pazzanese Institute of CardiologyMolecular Cardiology Research Laboratory, Dante Pazzanese Institute of CardiologyDepartment of Clinical and Toxicological Analysis, School of Pharmaceutical Sciences, University of São PauloAbstract 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.https://doi.org/10.1186/s13063-020-04809-xVolatile anestheticsCardiac anesthesiaCardiac surgerySystemic inflammatory responseCardiopulmonary bypass |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Thiago Augusto Azevedo Maranhão Cardoso Gudrun Kunst Caetano Nigro Neto José de Ribamar Costa Júnior Carlos Gustavo Santos Silva Gisele Medeiros Bastos Jéssica Bassani Borges Mario Hiroyuki Hirata |
spellingShingle |
Thiago Augusto Azevedo Maranhão Cardoso Gudrun Kunst Caetano Nigro Neto José de Ribamar Costa Júnior Carlos Gustavo Santos Silva Gisele Medeiros Bastos Jéssica Bassani Borges Mario Hiroyuki Hirata Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial Trials Volatile anesthetics Cardiac anesthesia Cardiac surgery Systemic inflammatory response Cardiopulmonary bypass |
author_facet |
Thiago Augusto Azevedo Maranhão Cardoso Gudrun Kunst Caetano Nigro Neto José de Ribamar Costa Júnior Carlos Gustavo Santos Silva Gisele Medeiros Bastos Jéssica Bassani Borges Mario Hiroyuki Hirata |
author_sort |
Thiago Augusto Azevedo Maranhão Cardoso |
title |
Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial |
title_short |
Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial |
title_full |
Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial |
title_fullStr |
Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial |
title_full_unstemmed |
Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial |
title_sort |
effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2021-01-01 |
description |
Abstract 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. |
topic |
Volatile anesthetics Cardiac anesthesia Cardiac surgery Systemic inflammatory response Cardiopulmonary bypass |
url |
https://doi.org/10.1186/s13063-020-04809-x |
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