Evidence mapPaperPMID 40187777Full record

ArticleBMJ open2025

'Transauricular vagus nerve stimulation' for prevention of postoperative delirium in elderly patients undergoing major surgery: a study protocol for a multicentre, participant-blinded and assessor-blinded, randomised, controlled trial.

Jun Zhang, Qi-Hong Shen, Xinru Lin, Tieshuai Liu, Yunyun Yu, Yu Li, Keqin Song, Xin Yu, Gang Chen

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Jun Zhang *Department of Anesthesiology, Zhejiang University School of Medicine Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China.ORCID http://orcid.org/0009-0003-7597-3376
Qi-Hong Shen *Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China.ORCID http://orcid.org/0000-0003-3365-779X
Xinru LinZhejiang University School of Medicine Sir Run Run Shaw Hospital, Hangzhou, China.ORCID http://orcid.org/0000-0001-5488-0881
Tieshuai LiuDepartment of Anesthesiology, Zhejiang University, Hangzhou, Zhejiang, China.
Yunyun YuDepartment of Anesthesiology, Lishui Central Hospital, Lishui, Zhejiang, China.
Yu LiDepartment of Anesthesiology, Wenzhou Central Hospital, Wenzhou, Zhejiang, China.
Keqin SongDepartment of Anesthesiology, Zhoushan Hospital, Zhoushan, Zhejiang, China.
Xin YuDepartment of Anesthesiology, Zhejiang University, Hangzhou, Zhejiang, China.
Gang ChenDepartment of Anesthesiology, Zhejiang University, Hangzhou, Zhejiang, China chengang120@zju.edu.cn.ORCID http://orcid.org/0000-0003-4262-9491

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPostoperative delirium (POD) is a frequent complication in elderly patients undergoing major surgery. Research has shown that neuroinflammation, postoperative pain and autonomic nervous system dysfunction play significant roles in its onset. Vagus nerve stimulation (VNS) has the potential to reduce inflammation, ease postoperative pain and aid in recovery by enhancing acetylcholine release and activating the cholinergic anti-inflammatory pathway. This study aims to assess the effectiveness and safety of transauricular VNS (ta-VNS) in preventing POD in elderly patients undergoing major surgery. METHODS AND ANALYSIS: This multicentre, participant-blinded and assessor-blinded, randomised, parallel-group controlled trial will compare the incidence of POD in elderly patients undergoing major surgery who receive ta-VNS versus sham stimulation. A total of 300 eligible patients will be randomly assigned in a 1:1 ratio to either the active or sham stimulation group. The active stimulation group will receive electrical stimulation to the left cymba conchae at a frequency of 30 Hz and a pulse width of 250 µs, with a 30 s on/30 s off cycle. The intensity will start at 0.4V and be increased in 0.4V increments until a tingling sensation is felt, then adjusted to the highest tolerable level without pain. After obtaining informed consent and randomisation, the initial intervention will begin in the preoperative area and continue throughout the surgery. For the four postoperative days, the intervention will be administered twice daily in 2-hour sessions each morning and afternoon. The sham group will follow the same procedure, with electrodes placed on the left cymba conchae. After adjusting the stimulation intensity, the device will be switched off. The primary outcome is the incidence of POD from postoperative day 0 to day 7 or discharge. Secondary outcomes include the severity of POD, quality of recovery, sleep quality and adverse events. ETHICS AND DISSEMINATION: The protocol was approved by Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine on 9 January 2024 (Approval number: 20240014), and the trial was registered on the Chinese Clinical Trial Registry on 21 February 2024, prior to recruitment. The study will be performed according to the guidelines of the Declaration of Helsinki. Written informed consent will be obtained from all participants. The results will be submitted for publication in a refereed journal. TRIAL REGISTRATION NUMBER: ChiCTR2400081078.

Indexed as

DeliriumPostoperative ComplicationsVagus Nerve StimulationAgedFemaleHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicDelirium & cognitive disordersGERIATRIC MEDICINEResearch Design

Identifiers

PMID40187777
PMCPMC11973790

What Socratic holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.