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NCT Number: NCT07045090

The Effect of Transcutaneous Electrical Acupoint Stimulation Combined With Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery

The aim of this clinical trial is to study the effect of transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation on postoperative delirium in elderly patients undergoing gastrointestinal surgery. The study aims to answer the following main questions

1. whether it reduces the expression of inflammatory factors in the acute postoperative period 2. whether it can reduce the incidence of postoperative delirium

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Key information

Conditions

Postoperative Delirium Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital Nantong University

Nantong, Jiangsu, 226000, China

About this study

Existing clinical studies have shown that TEAS has demonstrated value in preventing postoperative delirium (POD). Currently, taVNS is commonly used clinically to improve patients' cognitive dysfunction (POCD), and POD is often considered a precursor to the development of POCD. However, no one has yet used the two in combination, so this study aimed to combine the two to investigate their potential benefits in preventing POD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥65 years;
  • Body mass index (BMI) 18-30 kg/m²;
  • American Society of Anesthesiologists (ASA) physical status classification I-III;
  • Patients scheduled for elective laparoscopic gastrointestinal surgery;
  • Willingness to provide written informed consent and comply with the treatment regimen;
  • Absence of severe organic diseases, psychiatric disorders, or preoperative delirium.

Exclusion criteria

  • Preoperative Mini-Mental State Examination (MMSE) score <20;
  • Electrocardiographic evidence of severe bradycardia (heart rate <50 beats per minute);
  • Presence of skin lesions or infections at the electrical stimulation site;
  • History of preoperative chemotherapy or radiotherapy;
  • Concomitant severe organic diseases with compromised tolerance to interventions;
  • Prior exposure to Transcutaneous Electrical Acupoint Stimulation (TEAS) or transcutaneous auricular vagus nerve stimulation (taVNS) with documented insensitivity;
  • Inability to communicate normally, dementia, hearing impairment, or severe psychiatric disorders.

Treatment and study plan

Transcutaneous electrical acupoint stimulation

Device

Before induction of anaesthesia, electrodes were attached to selected acupoints and energised for 30 min, with the electrical stimulation parameter of dispersed dense wave (2/100 Hz), and the current intensity was based on the maximum current intensity that could be tolerated by the patient.

Transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation

Device

Before anaesthesia induction, the electrodes were attached to the selected acupoints and energized for 30 min, with the electrical stimulation parameters of dispersed dense wave (2/100Hz), and the current intensity was based on the maximum current intensity that the patient could tolerate. At the same time, the left ear auricular region was stimulated with a fasciculus nerve stimulator, the electrical stimulation parameters were: pulse width of 250 μs, pulse frequency of 20Hz, every 30s on, 30s off, and then 30s on again, the current intensity was based on the maximum current intensity that the patient could tolerate, for 30min.

Primary outcomes

  1. Incidence of postoperative delirium

    Time frame: The first to third days after surgery

    Whether delirium occurred after surgery（by 3D-CAM）

Secondary outcomes

  1. IL-6 andTNF-α level

    Time frame: before operation（Before anesthesia），the end of the operation（Immediately after the sewing is finished）

    the level of IL-6 andTNF-α in the participant's serum（by ELISA）

  2. VAS pain score

    Time frame: The first to third days after surgery

    Assessed with a VAS score scale, the highest is 10 and the lowest is 0, the higher the more severe the pain

  3. Early activities

    Time frame: Post-operative period until discharge（in about a week）

    The first time to be able to get out of bed and move

  4. Time to first postoperative anal defecation

    Time frame: Post-operative period until discharge（In about a week）

    Time to first postoperative anal defecation

  5. Adverse events

    Time frame: The first to third days after surgery

    Nausea and vomiting, sore throat, itching

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 1, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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