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

Affiliated Hospital of Nantong University

Status: Completed

Conditions: Postoperative Delirium

Treatments: Device: Transcutaneous electrical acupoint stimulation; Device: Transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07045090

2024-K071-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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116 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

Device: Transcutaneous electrical acupoint stimulation

Group B

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation