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

Not Applicable

Completed

• Conditions: Postoperative Delirium

• Registration Number: NCT07045090
• Lead Sponsor: Affiliated Hospital of Nantong University

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.

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-05-01
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-06-22
• Last Update Submitted: 2025-06-22
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative delirium	The first to third days after surgery	Whether delirium occurred after surgery（by 3D-CAM）

Secondary Outcome Measures

Name	Time	Method
IL-6 andTNF-α level	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）
Time to first postoperative anal defecation	Post-operative period until discharge（In about a week）	Time to first postoperative anal defecation
Early activities	Post-operative period until discharge（in about a week）	The first time to be able to get out of bed and move
VAS pain score	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
Adverse events	The first to third days after surgery	Nausea and vomiting, sore throat, itching

Trial Locations

Locations (1)

Affiliated Hospital Nantong University; 🇨🇳 Nantong, Jiangsu, China