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

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

doi:10.1186/s13063-020-04809-x

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

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

Cardiovascular Sciences

Dante Pazzanese Institute of Cardiology
Laboratory of Psychiatric Neuroimaging Institute, São Paulo, Brazil; Department of Psychiatry, São Paulo, Brazil; Center for Interdisciplinary Research on Applied Neurosciences, University of São Paulo, São Paulo, Brazil.

Research output: Contribution to journal › Article › peer-review

9 Citations (Scopus)

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.

Original language	English
Article number	25
Pages (from-to)	25
Journal	Trials
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s13063-020-04809-x
Publication status	Published - Dec 2021

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Cardoso, T. A. A. M., Kunst, G., Neto, C. N., de Ribamar Costa Júnior, J., Silva, C. G. S., Bastos, G. M., Borges, J. B., & Hirata, M. H. (2021). Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial. Trials, 22(1), 25. Article 25. https://doi.org/10.1186/s13063-020-04809-x

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title = "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 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.",

author = "Cardoso, {Thiago Augusto Azevedo Maranh{\~a}o} and Gudrun Kunst and Neto, {Caetano Nigro} and {de Ribamar Costa J{\'u}nior}, Jos{\'e} and Silva, {Carlos Gustavo Santos} and Bastos, {Gisele Medeiros} and Borges, {J{\'e}ssica Bassani} and Hirata, {Mario Hiroyuki}",

note = "Funding Information: This clinical trial is funded by the S{\~a}o Paulo State Research Foundation (FAPESP, acronym Portuguese), which supported the purchase of materials for the Molecular Biology Laboratory of the Dante Pazzanese Institute of Cardiology. The study design, results analysis, interpretation of the data, and writing of the manuscript were performed independently of the funding source. The grant number is 2017 / 21306-1. Funding Information: This clinical trial has been approved to receive funding from the S{\~a}o Paulo State Research Support Foundation (FAPESP, acronym Portuguese), (reference 2017/21306-1). Acknowledgements Publisher Copyright: {\textcopyright} 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",

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doi = "10.1186/s13063-020-04809-x",

language = "English",

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T1 - Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery

T2 - the study protocol for a randomized controlled trial

AU - Cardoso, Thiago Augusto Azevedo Maranhão

AU - Kunst, Gudrun

AU - Neto, Caetano Nigro

AU - de Ribamar Costa Júnior, José

AU - Silva, Carlos Gustavo Santos

AU - Bastos, Gisele Medeiros

AU - Borges, Jéssica Bassani

AU - Hirata, Mario Hiroyuki

N1 - Funding Information: This clinical trial is funded by the São Paulo State Research Foundation (FAPESP, acronym Portuguese), which supported the purchase of materials for the Molecular Biology Laboratory of the Dante Pazzanese Institute of Cardiology. The study design, results analysis, interpretation of the data, and writing of the manuscript were performed independently of the funding source. The grant number is 2017 / 21306-1. Funding Information: This clinical trial has been approved to receive funding from the São Paulo State Research Support Foundation (FAPESP, acronym Portuguese), (reference 2017/21306-1). Acknowledgements Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/12

Y1 - 2021/12

N2 - 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.

AB - 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.

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U2 - 10.1186/s13063-020-04809-x

DO - 10.1186/s13063-020-04809-x

M3 - Article

C2 - 33407763

SN - 1745-6215

VL - 22

SP - 25

JO - Trials

JF - Trials

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ER -

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

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