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已发表论文
经皮耳迷走神经刺激预防老年全膝关节置换术患者术后谵妄的多中心随机对照试验方案
Authors Liao X , Zhang T , Zhang J , Yang J, Li J , Chen L, Qian B
Received 12 June 2025
Accepted for publication 11 October 2025
Published 22 October 2025 Volume 2025:20 Pages 1787—1797
DOI https://doi.org/10.2147/CIA.S546762
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Zhi-Ying Wu
Xincheng Liao,1,* Tongtong Zhang,2,* Jingxuan Zhang,3 Jialin Yang,3 Junyu Li,3 Lei Chen,4 Bin Qian4
1Department of Anesthesiology, The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou, People’s Republic of China; 2Department of Anesthesiology, Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, People’s Republic of China; 3Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, People’s Republic of China; 4Department of Anesthesiology, People’s Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Fuzhou, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Junyu Li, Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, 134 Dongjie Street, Fuzhou, 350001, People’s Republic of China, Email lijunyu0907@163.com Lei Chen, Department of Anesthesiology, People’s Hospital Affiliated to Fujian University of Traditional Chinese Medicine, 602 Bayiqi Road, Fuzhou, 350005, People’s Republic of China, Email chenlei@fjtcm.edu.cn
Purpose: Postoperative delirium affects up to 65% of elderly surgical patients, leading to increased mortality and cognitive decline. Current prevention strategies face implementation barriers, necessitating accessible, non-pharmacological interventions. Transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive neuromodulation technique, reduces neuroinflammation and regulates autonomic function, offering potential for delirium prevention. This multicenter, randomized, double-blind, sham-controlled trial evaluates whether taVNS can prevent postoperative delirium in older adults undergoing total knee arthroplasty.
Patients and Methods: We will enroll 1448 patients aged 65– 80 years undergoing elective knee replacement under general anesthesia at four hospitals in Fujian Province, China. Participants will be randomized equally to receive active taVNS (25 Hz, 250 μs targeting the cymba conchae and tragus) or sham stimulation (25 Hz, 250 μs targeting the earlobe and antihelix). Both groups will receive interventions at two timepoints: the afternoon before surgery and the morning of surgery before anesthesia. The primary outcome is delirium incidence within 72 hours postoperatively, assessed using the Confusion Assessment Method. Secondary outcomes include inflammatory markers (interleukin-1, interleukin-6, tumor necrosis factor-alpha), autonomic function (heart rate variability), cognitive trajectories, psychological status, sleep quality, pain scores, and recovery parameters. Safety monitoring will follow standardized adverse event reporting guidelines.
Conclusion: If effective, taVNS could provide a practical, non-invasive method to reduce delirium incidence in elderly patients undergoing knee replacement, potentially improving postoperative outcomes and reducing healthcare costs.
Keywords: neuromodulation, cognitive complications, orthopedic surgery, inflammation, autonomic regulation
1Department of Anesthesiology, The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou, People’s Republic of China; 2Department of Anesthesiology, Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, People’s Republic of China; 3Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, People’s Republic of China; 4Department of Anesthesiology, People’s Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Fuzhou, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Junyu Li, Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, 134 Dongjie Street, Fuzhou, 350001, People’s Republic of China, Email lijunyu0907@163.com Lei Chen, Department of Anesthesiology, People’s Hospital Affiliated to Fujian University of Traditional Chinese Medicine, 602 Bayiqi Road, Fuzhou, 350005, People’s Republic of China, Email chenlei@fjtcm.edu.cn
Purpose: Postoperative delirium affects up to 65% of elderly surgical patients, leading to increased mortality and cognitive decline. Current prevention strategies face implementation barriers, necessitating accessible, non-pharmacological interventions. Transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive neuromodulation technique, reduces neuroinflammation and regulates autonomic function, offering potential for delirium prevention. This multicenter, randomized, double-blind, sham-controlled trial evaluates whether taVNS can prevent postoperative delirium in older adults undergoing total knee arthroplasty.
Patients and Methods: We will enroll 1448 patients aged 65– 80 years undergoing elective knee replacement under general anesthesia at four hospitals in Fujian Province, China. Participants will be randomized equally to receive active taVNS (25 Hz, 250 μs targeting the cymba conchae and tragus) or sham stimulation (25 Hz, 250 μs targeting the earlobe and antihelix). Both groups will receive interventions at two timepoints: the afternoon before surgery and the morning of surgery before anesthesia. The primary outcome is delirium incidence within 72 hours postoperatively, assessed using the Confusion Assessment Method. Secondary outcomes include inflammatory markers (interleukin-1, interleukin-6, tumor necrosis factor-alpha), autonomic function (heart rate variability), cognitive trajectories, psychological status, sleep quality, pain scores, and recovery parameters. Safety monitoring will follow standardized adverse event reporting guidelines.
Conclusion: If effective, taVNS could provide a practical, non-invasive method to reduce delirium incidence in elderly patients undergoing knee replacement, potentially improving postoperative outcomes and reducing healthcare costs.
Keywords: neuromodulation, cognitive complications, orthopedic surgery, inflammation, autonomic regulation