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The influence of TIVA or inhalation anesthesia with or without intravenous lidocaine on postoperative outcome in colorectal cancer surgery: a study protocol for a prospective clinical study

BACKGROUND: Anesthetic agents are mandatory in colorectal cancer patients undergoing surgery. Studies published so far have shown that anesthetic drugs and intervention may have different impacts on patient’s outcome. Among these drugs, propofol and, more recently, local anesthetics have been mostly...

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Autores principales: Alexa, Alexandru L., Tat, Tiberiu F., Ionescu, Daniela
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8932228/
https://www.ncbi.nlm.nih.gov/pubmed/35303929
http://dx.doi.org/10.1186/s13063-022-06157-4
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author Alexa, Alexandru L.
Tat, Tiberiu F.
Ionescu, Daniela
author_facet Alexa, Alexandru L.
Tat, Tiberiu F.
Ionescu, Daniela
author_sort Alexa, Alexandru L.
collection PubMed
description BACKGROUND: Anesthetic agents are mandatory in colorectal cancer patients undergoing surgery. Studies published so far have shown that anesthetic drugs and intervention may have different impacts on patient’s outcome. Among these drugs, propofol and, more recently, local anesthetics have been mostly targeted. METHODS/DESIGN: This study will be a prospective randomized control trial aiming to include 400 patients scheduled for curative colorectal surgery. Patients will be randomized to have general anesthesia with propofol or with sevoflurane. Each study group will be further divided into 2 subgroups of patients, of which one will receive intravenous lidocaine perioperatively. The primary outcome is to compare the incidence of cancer recurrence and survival after propofol versus sevoflurane anesthesia added or not intravenous lidocaine. Secondary outcomes will include the severity of postoperative pain, resumption of bowel function, morphine consumption, length of hospital stay, postoperative chronic pain, and rate of postoperative complications. DISCUSSION: To our knowledge, this is the first randomized control trial registered on ClinicalTrials.gov designed to compare the effects of two different anesthetic techniques added perioperative intravenous lidocaine infusion on long-term outcomes exclusively in colorectal cancer patients undergoing surgery. The study will bring more accurate data on the effect of propofol-TIVA and perioperative iv lidocaine on the incidence of recurrences after intended curative colorectal surgery. TRIAL REGISTRATION: Clinical Trial Registration NCT02786329. Registered on 1 June 2016 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06157-4.
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spelling pubmed-89322282022-03-23 The influence of TIVA or inhalation anesthesia with or without intravenous lidocaine on postoperative outcome in colorectal cancer surgery: a study protocol for a prospective clinical study Alexa, Alexandru L. Tat, Tiberiu F. Ionescu, Daniela Trials Study Protocol BACKGROUND: Anesthetic agents are mandatory in colorectal cancer patients undergoing surgery. Studies published so far have shown that anesthetic drugs and intervention may have different impacts on patient’s outcome. Among these drugs, propofol and, more recently, local anesthetics have been mostly targeted. METHODS/DESIGN: This study will be a prospective randomized control trial aiming to include 400 patients scheduled for curative colorectal surgery. Patients will be randomized to have general anesthesia with propofol or with sevoflurane. Each study group will be further divided into 2 subgroups of patients, of which one will receive intravenous lidocaine perioperatively. The primary outcome is to compare the incidence of cancer recurrence and survival after propofol versus sevoflurane anesthesia added or not intravenous lidocaine. Secondary outcomes will include the severity of postoperative pain, resumption of bowel function, morphine consumption, length of hospital stay, postoperative chronic pain, and rate of postoperative complications. DISCUSSION: To our knowledge, this is the first randomized control trial registered on ClinicalTrials.gov designed to compare the effects of two different anesthetic techniques added perioperative intravenous lidocaine infusion on long-term outcomes exclusively in colorectal cancer patients undergoing surgery. The study will bring more accurate data on the effect of propofol-TIVA and perioperative iv lidocaine on the incidence of recurrences after intended curative colorectal surgery. TRIAL REGISTRATION: Clinical Trial Registration NCT02786329. Registered on 1 June 2016 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06157-4. BioMed Central 2022-03-18 /pmc/articles/PMC8932228/ /pubmed/35303929 http://dx.doi.org/10.1186/s13063-022-06157-4 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
Alexa, Alexandru L.
Tat, Tiberiu F.
Ionescu, Daniela
The influence of TIVA or inhalation anesthesia with or without intravenous lidocaine on postoperative outcome in colorectal cancer surgery: a study protocol for a prospective clinical study
title The influence of TIVA or inhalation anesthesia with or without intravenous lidocaine on postoperative outcome in colorectal cancer surgery: a study protocol for a prospective clinical study
title_full The influence of TIVA or inhalation anesthesia with or without intravenous lidocaine on postoperative outcome in colorectal cancer surgery: a study protocol for a prospective clinical study
title_fullStr The influence of TIVA or inhalation anesthesia with or without intravenous lidocaine on postoperative outcome in colorectal cancer surgery: a study protocol for a prospective clinical study
title_full_unstemmed The influence of TIVA or inhalation anesthesia with or without intravenous lidocaine on postoperative outcome in colorectal cancer surgery: a study protocol for a prospective clinical study
title_short The influence of TIVA or inhalation anesthesia with or without intravenous lidocaine on postoperative outcome in colorectal cancer surgery: a study protocol for a prospective clinical study
title_sort influence of tiva or inhalation anesthesia with or without intravenous lidocaine on postoperative outcome in colorectal cancer surgery: a study protocol for a prospective clinical study
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8932228/
https://www.ncbi.nlm.nih.gov/pubmed/35303929
http://dx.doi.org/10.1186/s13063-022-06157-4
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