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      Intraoperative immunomodulatory effects of sevoflurane versus total intravenous anesthesia with propofol in bariatric surgery (the OBESITA trial): study protocol for a randomized controlled pilot trial

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          Abstract

          Background

          Obesity is associated with a chronic systemic inflammatory process. Volatile or intravenous anesthetic agents may modulate immune function, and may do so differentially in obesity. However, no study has evaluated whether these potential immunomodulatory effects differ according to type of anesthesia in obese patients undergoing laparoscopic bariatric surgery.

          Methods/design

          The OBESITA trial is a prospective, nonblinded, single-center, randomized, controlled clinical pilot trial. The trial will include 48 patients with a body mass index ≥ 35 kg/m 2, scheduled for laparoscopic bariatric surgery using sleeve or a Roux-en-Y gastric bypass technique, who will be allocated 1:1 to undergo general inhalational anesthesia with sevoflurane or total intravenous anesthesia (TIVA) with propofol. The primary endpoint is the difference in plasma interleukin (IL)-6 levels when comparing the two anesthetic agents. Blood samples will be collected prior to anesthesia induction (baseline), immediately after anesthetic induction, and before endotracheal extubation. Levels of other proinflammatory and anti-inflammatory cytokines, neutrophil chemotaxis, macrophage differentiation, phagocytosis, and occurrence of intraoperative and postoperative complications will also be evaluated.

          Discussion

          To our knowledge, this is the first randomized clinical trial designed to compare the effects of two different anesthetics on immunomodulation in obese patients undergoing laparoscopic bariatric surgery. Our hypothesis is that anesthesia with sevoflurane will result in a weaker proinflammatory response compared to anesthesia with propofol, with lower circulating levels of IL-6 and other proinflammatory mediators, and increased macrophage differentiation into the M2 phenotype in adipose tissue.

          Trial registration

          Registro Brasileiro de Ensaios Clínicos, RBR-77kfj5. Registered on 25 July 2018.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-019-3399-z) contains supplementary material, which is available to authorized users.

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          Most cited references88

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          Origin and physiological roles of inflammation.

          Inflammation underlies a wide variety of physiological and pathological processes. Although the pathological aspects of many types of inflammation are well appreciated, their physiological functions are mostly unknown. The classic instigators of inflammation - infection and tissue injury - are at one end of a large range of adverse conditions that induce inflammation, and they trigger the recruitment of leukocytes and plasma proteins to the affected tissue site. Tissue stress or malfunction similarly induces an adaptive response, which is referred to here as para-inflammation. This response relies mainly on tissue-resident macrophages and is intermediate between the basal homeostatic state and a classic inflammatory response. Para-inflammation is probably responsible for the chronic inflammatory conditions that are associated with modern human diseases.
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            Old, new and emerging functions of caspases.

            Caspases are proteases with a well-defined role in apoptosis. However, increasing evidence indicates multiple functions of caspases outside apoptosis. Caspase-1 and caspase-11 have roles in inflammation and mediating inflammatory cell death by pyroptosis. Similarly, caspase-8 has dual role in cell death, mediating both receptor-mediated apoptosis and in its absence, necroptosis. Caspase-8 also functions in maintenance and homeostasis of the adult T-cell population. Caspase-3 has important roles in tissue differentiation, regeneration and neural development in ways that are distinct and do not involve any apoptotic activity. Several other caspases have demonstrated anti-tumor roles. Notable among them are caspase-2, -8 and -14. However, increased caspase-2 and -8 expression in certain types of tumor has also been linked to promoting tumorigenesis. Increased levels of caspase-3 in tumor cells causes apoptosis and secretion of paracrine factors that promotes compensatory proliferation in surrounding normal tissues, tumor cell repopulation and presents a barrier for effective therapeutic strategies. Besides this caspase-2 has emerged as a unique caspase with potential roles in maintaining genomic stability, metabolism, autophagy and aging. The present review focuses on some of these less studied and emerging functions of mammalian caspases.
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              Interleukin-6-deficient mice develop mature-onset obesity.

              The immune-modulating cytokine interleukin-6 (IL-6) is expressed both in adipose tissue and centrally in hypothalamic nuclei that regulate body composition. We investigated the impact of loss of IL-6 on body composition in mice lacking the gene encoding IL-6 (Il6-/- mice) and found that they developed mature-onset obesity that was partly reversed by IL-6 replacement. The obese Il6-/- mice had disturbed carbohydrate and lipid metabolism, increased leptin levels and decreased responsiveness to leptin treatment. To investigate the possible mechanism and site of action of the anti-obesity effect of IL-6, we injected rats centrally and peripherally with IL-6 at low doses. Intracerebroventricular, but not intraperitoneal IL-6 treatment increased energy expenditure. In conclusion, centrally acting IL-6 exerts anti-obesity effects in rodents.
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                Author and article information

                Contributors
                +55 21 3938-6530 , prmrocco@gmail.com
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                28 May 2019
                28 May 2019
                2019
                : 20
                : 300
                Affiliations
                [1 ]ISNI 0000 0001 2294 473X, GRID grid.8536.8, Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, , Federal University of Rio de Janeiro, Centro de Ciências da Saúde, ; Avenida Carlos Chagas Filho, 373, Bloco G1-014, Ilha do Fundão, Rio de Janeiro, 21941-902 Brazil
                [2 ]ISNI 0000 0001 2294 473X, GRID grid.8536.8, Department of Anesthesiology, , Federal University of Rio de Janeiro, ; Rio de Janeiro, Brazil
                [3 ]Institute D’Or of Research and Teaching, Rio de Janeiro, Brazil
                [4 ]ISNI 0000000084992262, GRID grid.7177.6, Department of Intensive Care and Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), , Amsterdam University Medical Centers, University of Amsterdam, ; Amsterdam, The Netherlands
                [5 ]ISNI 0000 0004 1937 0490, GRID grid.10223.32, Mahidol Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, , Mahidol University, ; Bangkok, Thailand
                [6 ]ISNI 0000 0001 2151 3065, GRID grid.5606.5, Department of Surgical Sciences and Integrated Diagnostics, , University of Genoa, ; Genoa, Italy
                [7 ]Ospedale Policlinico San Martino, IRCCS for Oncology and Neurosciences, Genoa, Italy
                [8 ]ISNI 0000 0001 1091 2917, GRID grid.412282.f, Pulmonary Engineering Group, Department of Anesthesiology and Intensive Care Medicine, , University Hospital Carl Gustav Carus, ; Dresden, Germany
                Author information
                http://orcid.org/0000-0003-1412-7136
                Article
                3399
                10.1186/s13063-019-3399-z
                6540380
                31138279
                1548e699-b0d3-416a-a27b-28773232f2b3
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 30 October 2018
                : 6 May 2019
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100003593, Conselho Nacional de Desenvolvimento Científico e Tecnológico;
                Award ID: 421067/2016-0
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2019

                Medicine
                obesity,inflammation,cytokines,interleukin 6,lung injury,propofol,sevoflurane,clinical trial
                Medicine
                obesity, inflammation, cytokines, interleukin 6, lung injury, propofol, sevoflurane, clinical trial

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