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

NCT07045090 | Completed

• 1 other identifier: 2024-K071-01
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Delirium

Keywords

Elderly patients; postoperative delirium; gastrointestinal surgery; Auricular vagus nerve stimulation; Transcutaneous electrical acupoint stimulation

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium

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

  The first to third days after surgery

Secondary Outcomes (5)

• IL-6 andTNF-α level

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

• VAS pain score

  The first to third days after surgery

• Early activities

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

• Time to first postoperative anal defecation

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

• Adverse events

  The first to third days after surgery

Study Arms (2)

Group A

EXPERIMENTAL

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

Device: Transcutaneous electrical acupoint stimulation

Group B

EXPERIMENTAL

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.

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

Interventions

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.

Group A

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.

Group B

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital Nantong University

Nantong, Jiangsu, 226000, China

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Lulu Ji

  Affiliated Hospital of Nantong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: July 1, 2025
• Study Start: May 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 1, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)