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Efficiency of probiotics in elderly patients undergoing orthopedic surgery for postoperative cognitive dysfunction: a study protocol for a multicenter, randomized controlled trial

BACKGROUND: Postoperative cognitive dysfunction (POCD) refers to a neurological dysfunction after a major surgery and anesthesia. It is common in elderly patients and is characterized by impairment in consciousness, orientation, thinking, memory, and executive function after surgical anesthesia. How...

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Autores principales: Zhang, Xiaoyi, Chen, Yuwen, Tang, Ying, Zhang, Yizhe, Zhang, Xiao, Su, Diansan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9960477/
https://www.ncbi.nlm.nih.gov/pubmed/36841790
http://dx.doi.org/10.1186/s13063-023-07167-6
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author Zhang, Xiaoyi
Chen, Yuwen
Tang, Ying
Zhang, Yizhe
Zhang, Xiao
Su, Diansan
author_facet Zhang, Xiaoyi
Chen, Yuwen
Tang, Ying
Zhang, Yizhe
Zhang, Xiao
Su, Diansan
author_sort Zhang, Xiaoyi
collection PubMed
description BACKGROUND: Postoperative cognitive dysfunction (POCD) refers to a neurological dysfunction after a major surgery and anesthesia. It is common in elderly patients and is characterized by impairment in consciousness, orientation, thinking, memory, and executive function after surgical anesthesia. However, at present, there is no definite preventive or treatable strategy for it. Previous animal experiments showed that giving probiotics to mice before operation can prevent POCD, but there is a lack of clinical evidence. This study aims to intervene with the intestinal flora imbalance using probiotics during the perioperative period to reduce the incidence of POCD in elderly patients after orthopedic surgery and to provide new ideas and methods for the clinical prevention and treatment of POCD. METHODS: A multicenter, double-blind, placebo-controlled clinical trial will be performed to evaluate the efficacy of probiotics in elderly patients undergoing orthopedic surgery. Participants (n = 220) will receive probiotics (Peifeikang, Live Combined Bifidobacterium, 210 mg per capsule, twice a day, four capsules each time, which contains Bifidobacterium longum, Lactobacillus acidophilus and Streptococcus faecalis no less than 1.0 × 10(7) CFU viable bacteria respectively) or placebo from 1 day before surgery to 6 days after surgery. Neuropsychological tests will be performed 1 day before surgery and 1 week and 1 month after surgery. The main outcome of this study is the incidence of POCD 7 days after surgery. Our secondary objective is to assess the incidence of POCD 1 month after surgery; the cognitive status will be determined based on a telephone interview and will be evaluated via TICS-m; postoperative delirium will be assessed 7 days after surgery using the Confusion Assessment Method (CAM). DISCUSSION: Discovering the correlation between the intestinal microbiota and POCD is an important breakthrough. Based on the key role of the intestinal microbiota in other cognitive disorders, we hope that probiotics can reduce its incidence in elderly orthopedic patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04017403. Registered on August 15, 2019. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07167-6.
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spelling pubmed-99604772023-02-26 Efficiency of probiotics in elderly patients undergoing orthopedic surgery for postoperative cognitive dysfunction: a study protocol for a multicenter, randomized controlled trial Zhang, Xiaoyi Chen, Yuwen Tang, Ying Zhang, Yizhe Zhang, Xiao Su, Diansan Trials Study Protocol BACKGROUND: Postoperative cognitive dysfunction (POCD) refers to a neurological dysfunction after a major surgery and anesthesia. It is common in elderly patients and is characterized by impairment in consciousness, orientation, thinking, memory, and executive function after surgical anesthesia. However, at present, there is no definite preventive or treatable strategy for it. Previous animal experiments showed that giving probiotics to mice before operation can prevent POCD, but there is a lack of clinical evidence. This study aims to intervene with the intestinal flora imbalance using probiotics during the perioperative period to reduce the incidence of POCD in elderly patients after orthopedic surgery and to provide new ideas and methods for the clinical prevention and treatment of POCD. METHODS: A multicenter, double-blind, placebo-controlled clinical trial will be performed to evaluate the efficacy of probiotics in elderly patients undergoing orthopedic surgery. Participants (n = 220) will receive probiotics (Peifeikang, Live Combined Bifidobacterium, 210 mg per capsule, twice a day, four capsules each time, which contains Bifidobacterium longum, Lactobacillus acidophilus and Streptococcus faecalis no less than 1.0 × 10(7) CFU viable bacteria respectively) or placebo from 1 day before surgery to 6 days after surgery. Neuropsychological tests will be performed 1 day before surgery and 1 week and 1 month after surgery. The main outcome of this study is the incidence of POCD 7 days after surgery. Our secondary objective is to assess the incidence of POCD 1 month after surgery; the cognitive status will be determined based on a telephone interview and will be evaluated via TICS-m; postoperative delirium will be assessed 7 days after surgery using the Confusion Assessment Method (CAM). DISCUSSION: Discovering the correlation between the intestinal microbiota and POCD is an important breakthrough. Based on the key role of the intestinal microbiota in other cognitive disorders, we hope that probiotics can reduce its incidence in elderly orthopedic patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04017403. Registered on August 15, 2019. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07167-6. BioMed Central 2023-02-25 /pmc/articles/PMC9960477/ /pubmed/36841790 http://dx.doi.org/10.1186/s13063-023-07167-6 Text en © The Author(s) 2023 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
Zhang, Xiaoyi
Chen, Yuwen
Tang, Ying
Zhang, Yizhe
Zhang, Xiao
Su, Diansan
Efficiency of probiotics in elderly patients undergoing orthopedic surgery for postoperative cognitive dysfunction: a study protocol for a multicenter, randomized controlled trial
title Efficiency of probiotics in elderly patients undergoing orthopedic surgery for postoperative cognitive dysfunction: a study protocol for a multicenter, randomized controlled trial
title_full Efficiency of probiotics in elderly patients undergoing orthopedic surgery for postoperative cognitive dysfunction: a study protocol for a multicenter, randomized controlled trial
title_fullStr Efficiency of probiotics in elderly patients undergoing orthopedic surgery for postoperative cognitive dysfunction: a study protocol for a multicenter, randomized controlled trial
title_full_unstemmed Efficiency of probiotics in elderly patients undergoing orthopedic surgery for postoperative cognitive dysfunction: a study protocol for a multicenter, randomized controlled trial
title_short Efficiency of probiotics in elderly patients undergoing orthopedic surgery for postoperative cognitive dysfunction: a study protocol for a multicenter, randomized controlled trial
title_sort efficiency of probiotics in elderly patients undergoing orthopedic surgery for postoperative cognitive dysfunction: a study protocol for a multicenter, randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9960477/
https://www.ncbi.nlm.nih.gov/pubmed/36841790
http://dx.doi.org/10.1186/s13063-023-07167-6
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