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经皮耳迷走神经刺激预防老年患者术后谵妄(VNSTAR):一项多中心随机对照试验方案

Transcutaneous auricular vagus nerve stimulation prevents postoperative delirium in elderly patients (VNSTAR): protocol for a multicentre, randomised controlled trial.

作者信息

Wu Youxuan, Hou Xuan, Wang Tianyuan, Wang Xinyan, Zhang Kangda, Liang Fa, Jian Minyu, Wang Bo, Liu Haiyang, Wang Anxin, Han Ruquan

机构信息

Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing, China.

Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing, China.

出版信息

BMJ Open. 2025 May 30;15(5):e099736. doi: 10.1136/bmjopen-2025-099736.


DOI:10.1136/bmjopen-2025-099736
PMID:40447430
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12128425/
Abstract

INTRODUCTION: Postoperative delirium (POD) is a common complication in elderly patients and is closely associated with delayed recovery, prolonged hospital stays, increased mortality rates and increased medical expenses. Vagus nerve stimulation, a novel technique in the field of neuroscience, has demonstrated remarkable therapeutic potential in improving neurocognitive disorders. However, its applicability in ameliorating neurocognitive dysfunctions that arise during the perioperative period remains unclear. To date, no large prospective, randomised controlled studies have explored the effects of vagus nerve stimulation on POD. METHOD AND ANALYSIS: This study is a multicentre, double-blind, parallel, randomised controlled trial. It aims to explore the preventative effects of transcutaneous auricular vagus nerve stimulation on POD in elderly patients who are scheduled for elective surgery at several medical institutions in China from 2024 to 2027. The estimated sample size is 1776, with half of the patients randomly assigned to receive prophylactic standard transauricular auricular vagus nerve stimulation during the perioperative period (allocation ratio 1:1). The primary outcome measure is the incidence of POD within 5 days after surgery. ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of Beijing Tiantan Hospital, Capital Medical University and adheres to the principles of the Declaration of Helsinki. The protocol was written in accordance with the 2013 Standard Protocol Items: Recommendations for Interventional Trials guidelines. The results of this study will be published in a peer-reviewed journal and presented at national or international conferences. TRIAL REGISTRATION NUMBER: NCT06421077.

摘要

引言:术后谵妄(POD)是老年患者常见的并发症,与恢复延迟、住院时间延长、死亡率增加及医疗费用增加密切相关。迷走神经刺激是神经科学领域的一项新技术,在改善神经认知障碍方面已显示出显著的治疗潜力。然而,其在改善围手术期出现的神经认知功能障碍方面的适用性仍不明确。迄今为止,尚无大型前瞻性随机对照研究探讨迷走神经刺激对术后谵妄的影响。 方法与分析:本研究为多中心、双盲、平行随机对照试验。旨在探讨经皮耳迷走神经刺激对2024年至2027年在中国多家医疗机构计划进行择期手术的老年患者术后谵妄的预防作用。估计样本量为1776例,其中一半患者随机分配在围手术期接受预防性标准经皮耳迷走神经刺激(分配比例1:1)。主要结局指标是术后5天内术后谵妄的发生率。 伦理与传播:本研究经首都医科大学附属北京天坛医院伦理委员会批准,遵循《赫尔辛基宣言》的原则。该方案按照2013年《标准方案条目:干预试验建议》指南编写。本研究结果将发表在同行评审期刊上,并在国内或国际会议上展示。 试验注册号:NCT06421077。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac97/12128425/1726b453a85b/bmjopen-15-5-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac97/12128425/e0a873360fdc/bmjopen-15-5-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac97/12128425/1726b453a85b/bmjopen-15-5-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac97/12128425/e0a873360fdc/bmjopen-15-5-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac97/12128425/1726b453a85b/bmjopen-15-5-g002.jpg

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本文引用的文献

[1]
Vagus nerve stimulation: a physical therapy with promising potential for central nervous system disorders.

Front Neurol. 2024-12-13

[2]
The effects of transcutaneous auricular vagus nerve stimulation (taVNS) on cholinergic neural networks in humans: A neurophysiological study.

Clin Neurophysiol. 2025-1

[3]
The Pathophysiology and Biomarkers of Delirium.

Semin Neurol. 2024-12

[4]
Suvorexant for Reduction of Delirium in Older Adults After Hospitalization: A Randomized Clinical Trial.

JAMA Netw Open. 2024-8-1

[5]
Interventions to prevent and treat delirium: An umbrella review of randomized controlled trials.

Ageing Res Rev. 2024-6

[6]
Transcutaneous auricular vagus nerve stimulation in the treatment of disorders of consciousness: mechanisms and applications.

Front Neurosci. 2023-10-18

[7]
Neural, Anti-Inflammatory, and Clinical Effects of Transauricular Vagus Nerve Stimulation in Major Depressive Disorder: A Systematic Review.

Int J Neuropsychopharmacol. 2024-3-1

[8]
The Effect of taVNS on the Cerebello-Thalamo-Cortical Pathway: a TMS Study.

Cerebellum. 2024-6

[9]
Update of the European Society of Anaesthesiology and Intensive Care Medicine evidence-based and consensus-based guideline on postoperative delirium in adult patients.

Eur J Anaesthesiol. 2024-2-1

[10]
Transcutaneous auricular vagus nerve stimulation improves working memory in temporal lobe epilepsy: A randomized double-blind study.

CNS Neurosci Ther. 2024-2

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