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Protocol: dexmedetomidine on myocardial injury after noncardiac surgery—a multicenter, double-blind, controlled trial

AIMS: Myocardial injury after noncardiac surgery (MINS) is common in elderly patients and considered as an independent predictor of 30-day mortality after noncardiac surgery. Dexmedetomidine possesses cardiac-protective profile. Previous clinical studies have found that perioperative application of...

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Autores principales: Liu, Huayue, Zhang, Juan, Peng, Ke, Meng, Xiaowen, Shan, Xisheng, Huo, Wenwen, Liu, Hong, Lei, Yishan, Ji, Fuhai
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10638683/
https://www.ncbi.nlm.nih.gov/pubmed/37951962
http://dx.doi.org/10.1186/s13741-023-00348-6
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author Liu, Huayue
Zhang, Juan
Peng, Ke
Meng, Xiaowen
Shan, Xisheng
Huo, Wenwen
Liu, Hong
Lei, Yishan
Ji, Fuhai
author_facet Liu, Huayue
Zhang, Juan
Peng, Ke
Meng, Xiaowen
Shan, Xisheng
Huo, Wenwen
Liu, Hong
Lei, Yishan
Ji, Fuhai
author_sort Liu, Huayue
collection PubMed
description AIMS: Myocardial injury after noncardiac surgery (MINS) is common in elderly patients and considered as an independent predictor of 30-day mortality after noncardiac surgery. Dexmedetomidine possesses cardiac-protective profile. Previous clinical studies have found that perioperative application of dexmedetomidine is associated with decreased 1-year mortality in patients undergoing cardiac surgery. The current study protocol aims to investigate the effects of dexmedetomidine on the incidence of MINS, complications, and 30-day mortality in elderly patients subjected to noncardiac surgery. METHODS: A multicenter, randomized, controlled, double-blind, prospective trial is designed to explore cardiac protection of dexmedetomidine in the elderly patients undergoing noncardiac surgery. A total of 960 patients aged over 65 years will be recruited and randomly assigned to dexmedetomidine group (group Dex) and normal saline placebo group (group NS) in a ratio of 1:1. Patients in group Dex will receive a bolus dose of 0.5 μg/kg dexmedetomidine within 10 min before surgical incision, followed by a consistent infusion at the rate of 0.3–0.5 μg/kg/h throughout the operation. Group NS patients will receive the same volume of normal saline. The primary outcome is the incidence of MINS via detecting the hs-TnT level within 3 days after the operation. The secondary outcome includes myocardial ischemic symptoms, the incidence of major adverse cardiovascular events (MACE) in hospital, length of ICU and postoperative hospital stay, the incidence of inhospital complications, and 30-day all-cause mortality. DISCUSSION: The results of the current study will illustrate the effect of dexmedetomidine on myocardial injury for elderly patients undergoing major noncardiac surgery. TRIAL REGISTRATION: The trial was registered with Chinese Clinical Trial Registry (CHICTR) on Aug 24, 2021 (ChiCTR2100049946, http://www.chictr.org.cn/showproj.aspx?proj=131804).
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spelling pubmed-106386832023-11-11 Protocol: dexmedetomidine on myocardial injury after noncardiac surgery—a multicenter, double-blind, controlled trial Liu, Huayue Zhang, Juan Peng, Ke Meng, Xiaowen Shan, Xisheng Huo, Wenwen Liu, Hong Lei, Yishan Ji, Fuhai Perioper Med (Lond) Study Protocol AIMS: Myocardial injury after noncardiac surgery (MINS) is common in elderly patients and considered as an independent predictor of 30-day mortality after noncardiac surgery. Dexmedetomidine possesses cardiac-protective profile. Previous clinical studies have found that perioperative application of dexmedetomidine is associated with decreased 1-year mortality in patients undergoing cardiac surgery. The current study protocol aims to investigate the effects of dexmedetomidine on the incidence of MINS, complications, and 30-day mortality in elderly patients subjected to noncardiac surgery. METHODS: A multicenter, randomized, controlled, double-blind, prospective trial is designed to explore cardiac protection of dexmedetomidine in the elderly patients undergoing noncardiac surgery. A total of 960 patients aged over 65 years will be recruited and randomly assigned to dexmedetomidine group (group Dex) and normal saline placebo group (group NS) in a ratio of 1:1. Patients in group Dex will receive a bolus dose of 0.5 μg/kg dexmedetomidine within 10 min before surgical incision, followed by a consistent infusion at the rate of 0.3–0.5 μg/kg/h throughout the operation. Group NS patients will receive the same volume of normal saline. The primary outcome is the incidence of MINS via detecting the hs-TnT level within 3 days after the operation. The secondary outcome includes myocardial ischemic symptoms, the incidence of major adverse cardiovascular events (MACE) in hospital, length of ICU and postoperative hospital stay, the incidence of inhospital complications, and 30-day all-cause mortality. DISCUSSION: The results of the current study will illustrate the effect of dexmedetomidine on myocardial injury for elderly patients undergoing major noncardiac surgery. TRIAL REGISTRATION: The trial was registered with Chinese Clinical Trial Registry (CHICTR) on Aug 24, 2021 (ChiCTR2100049946, http://www.chictr.org.cn/showproj.aspx?proj=131804). BioMed Central 2023-11-11 /pmc/articles/PMC10638683/ /pubmed/37951962 http://dx.doi.org/10.1186/s13741-023-00348-6 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This 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
Liu, Huayue
Zhang, Juan
Peng, Ke
Meng, Xiaowen
Shan, Xisheng
Huo, Wenwen
Liu, Hong
Lei, Yishan
Ji, Fuhai
Protocol: dexmedetomidine on myocardial injury after noncardiac surgery—a multicenter, double-blind, controlled trial
title Protocol: dexmedetomidine on myocardial injury after noncardiac surgery—a multicenter, double-blind, controlled trial
title_full Protocol: dexmedetomidine on myocardial injury after noncardiac surgery—a multicenter, double-blind, controlled trial
title_fullStr Protocol: dexmedetomidine on myocardial injury after noncardiac surgery—a multicenter, double-blind, controlled trial
title_full_unstemmed Protocol: dexmedetomidine on myocardial injury after noncardiac surgery—a multicenter, double-blind, controlled trial
title_short Protocol: dexmedetomidine on myocardial injury after noncardiac surgery—a multicenter, double-blind, controlled trial
title_sort protocol: dexmedetomidine on myocardial injury after noncardiac surgery—a multicenter, double-blind, controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10638683/
https://www.ncbi.nlm.nih.gov/pubmed/37951962
http://dx.doi.org/10.1186/s13741-023-00348-6
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