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Effect of anesthesia on the outcome of high-grade glioma patients undergoing supratentorial resection: study protocol for a pragmatic randomized controlled trial

BACKGROUND: High-grade glioma (HGG) is the most malignant brain tumor with poor outcomes. Whether anesthetic methods have an impact on the outcome of these patients is still unknown. Retrospective study has found no difference between intravenous and inhalation anesthesia on the overall survival (OS...

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Autores principales: Dong, Jia, Wang, Dexiang, Sun, Huizhong, Zeng, Min, Liu, Xiaoyuan, Yan, Xiang, Li, Ruowen, Li, Shu, Peng, Yuming
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9513932/
https://www.ncbi.nlm.nih.gov/pubmed/36167574
http://dx.doi.org/10.1186/s13063-022-06716-9
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author Dong, Jia
Wang, Dexiang
Sun, Huizhong
Zeng, Min
Liu, Xiaoyuan
Yan, Xiang
Li, Ruowen
Li, Shu
Peng, Yuming
author_facet Dong, Jia
Wang, Dexiang
Sun, Huizhong
Zeng, Min
Liu, Xiaoyuan
Yan, Xiang
Li, Ruowen
Li, Shu
Peng, Yuming
author_sort Dong, Jia
collection PubMed
description BACKGROUND: High-grade glioma (HGG) is the most malignant brain tumor with poor outcomes. Whether anesthetic methods have an impact on the outcome of these patients is still unknown. Retrospective study has found no difference between intravenous and inhalation anesthesia on the overall survival (OS) of the HGG patients, however, intravenous anesthesia with propofol might be beneficial in a subgroup of patients with a Karnofsky Performance Status (KPS) Scale less than 80. Further prospective studies are needed to evaluate the results. METHODS: This is a single-centered, randomized controlled, parallel-group trial. Three hundred forty-four patients with primary HGG for tumor resection will be randomly assigned to receive either intravenous anesthesia with propofol or inhalation anesthesia with sevoflurane. The primary outcome is the OS of the patients within 18 months. Secondary outcomes include progression-free survival (PFS), the numerical rating scale (NRS) of pain intensity and sleep quality, the postoperative encephaloedema volume, complications, and the length of hospital stay of the patients. DISCUSSION: This is a randomized controlled trial to compare the effect of intravenous and inhalation anesthesia maintenance on the outcome of supratentorial HGG patients. The results will contribute to optimizing the anesthesia methods in these patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT02756312. Registered on 29 April 2016 and last updated on 9 Sep 2020 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06716-9.
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spelling pubmed-95139322022-09-28 Effect of anesthesia on the outcome of high-grade glioma patients undergoing supratentorial resection: study protocol for a pragmatic randomized controlled trial Dong, Jia Wang, Dexiang Sun, Huizhong Zeng, Min Liu, Xiaoyuan Yan, Xiang Li, Ruowen Li, Shu Peng, Yuming Trials Study Protocol BACKGROUND: High-grade glioma (HGG) is the most malignant brain tumor with poor outcomes. Whether anesthetic methods have an impact on the outcome of these patients is still unknown. Retrospective study has found no difference between intravenous and inhalation anesthesia on the overall survival (OS) of the HGG patients, however, intravenous anesthesia with propofol might be beneficial in a subgroup of patients with a Karnofsky Performance Status (KPS) Scale less than 80. Further prospective studies are needed to evaluate the results. METHODS: This is a single-centered, randomized controlled, parallel-group trial. Three hundred forty-four patients with primary HGG for tumor resection will be randomly assigned to receive either intravenous anesthesia with propofol or inhalation anesthesia with sevoflurane. The primary outcome is the OS of the patients within 18 months. Secondary outcomes include progression-free survival (PFS), the numerical rating scale (NRS) of pain intensity and sleep quality, the postoperative encephaloedema volume, complications, and the length of hospital stay of the patients. DISCUSSION: This is a randomized controlled trial to compare the effect of intravenous and inhalation anesthesia maintenance on the outcome of supratentorial HGG patients. The results will contribute to optimizing the anesthesia methods in these patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT02756312. Registered on 29 April 2016 and last updated on 9 Sep 2020 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06716-9. BioMed Central 2022-09-27 /pmc/articles/PMC9513932/ /pubmed/36167574 http://dx.doi.org/10.1186/s13063-022-06716-9 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Dong, Jia
Wang, Dexiang
Sun, Huizhong
Zeng, Min
Liu, Xiaoyuan
Yan, Xiang
Li, Ruowen
Li, Shu
Peng, Yuming
Effect of anesthesia on the outcome of high-grade glioma patients undergoing supratentorial resection: study protocol for a pragmatic randomized controlled trial
title Effect of anesthesia on the outcome of high-grade glioma patients undergoing supratentorial resection: study protocol for a pragmatic randomized controlled trial
title_full Effect of anesthesia on the outcome of high-grade glioma patients undergoing supratentorial resection: study protocol for a pragmatic randomized controlled trial
title_fullStr Effect of anesthesia on the outcome of high-grade glioma patients undergoing supratentorial resection: study protocol for a pragmatic randomized controlled trial
title_full_unstemmed Effect of anesthesia on the outcome of high-grade glioma patients undergoing supratentorial resection: study protocol for a pragmatic randomized controlled trial
title_short Effect of anesthesia on the outcome of high-grade glioma patients undergoing supratentorial resection: study protocol for a pragmatic randomized controlled trial
title_sort effect of anesthesia on the outcome of high-grade glioma patients undergoing supratentorial resection: study protocol for a pragmatic randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9513932/
https://www.ncbi.nlm.nih.gov/pubmed/36167574
http://dx.doi.org/10.1186/s13063-022-06716-9
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