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

NCT ID: NCT07045090

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-11-01

Brief Summary

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

Detailed Description

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.

Conditions

Postoperative Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group A

Prior to induction of anaesthesia, patients in this group received transcutaneous electrical stimulation of acupuncture points for 30 min, followed by standardised anaesthesia.

Group Type: EXPERIMENTAL

Transcutaneous electrical acupoint stimulation

Intervention Type: 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.

Group B

Prior to induction of anaesthesia, patients in this group received transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation for a total of 30 min, followed by standardised anaesthesia.

Group Type: EXPERIMENTAL

Transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation

Intervention Type: 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.

Interventions

Transcutaneous electrical acupoint stimulation

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.

Intervention Type: DEVICE

Transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Aged ≥65 years;

2. Body mass index (BMI) 18-30 kg/m²;

3. American Society of Anesthesiologists (ASA) physical status classification I-III;

4. Patients scheduled for elective laparoscopic gastrointestinal surgery;

5. Willingness to provide written informed consent and comply with the treatment regimen;

6. Absence of severe organic diseases, psychiatric disorders, or preoperative delirium.

Exclusion Criteria

1. Preoperative Mini-Mental State Examination (MMSE) score <20;

2. Electrocardiographic evidence of severe bradycardia (heart rate <50 beats per minute);

3. Presence of skin lesions or infections at the electrical stimulation site;

4. History of preoperative chemotherapy or radiotherapy;

5. Concomitant severe organic diseases with compromised tolerance to interventions;

6. Prior exposure to Transcutaneous Electrical Acupoint Stimulation (TEAS) or transcutaneous auricular vagus nerve stimulation (taVNS) with documented insensitivity;

7. Inability to communicate normally, dementia, hearing impairment, or severe psychiatric disorders.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Lulu Ji

Attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lulu Ji

Role: STUDY_DIRECTOR

Affiliated Hospital of Nantong University

Locations

Affiliated Hospital Nantong University

Nantong, Jiangsu, China

Countries

China

Other Identifiers

2024-K071-01

Identifier Type: -

Identifier Source: org_study_id