taVNS Reduces Postoperative Pain and Complications in Patients With Gastric and Intestinal Tumors

NCT06763913 | Completed DMC

• 1 other identifier: 2024-1127
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative acute pain control in patients with gastrointestinal tumors is not satisfactory, and surgical complications including gastrointestinal dysfunction, gastrointestinal fistula, abdominal and gastrointestinal hemorrhage, peritonitis and abscess, are still important factors affecting surgical outcomes, postoperative recovery, hospital stay, and even perioperative mortality. The application of taVNS during the perioperative period can enhance or preserve vagal nerve function, which may protect important organ functions through multiple pathways such as alleviating pain and inflammatory responses caused by surgical trauma, improving gastrointestinal function, enhancing cardiovascular regulation, reducing postoperative nausea and vomiting, and accelerating postoperative recovery, thereby reducing postoperative complications and mortality.

Conditions

taVNS; Gastrointestinal Tumor Surgery; Visual Analogue Scale; Complications

Keywords

taVNS; Perioperative period; Visual Analogue Scale; complications

Outcome Measures

Primary Outcomes (1)

• Difference in VAS Score on Postoperative Day 1

  Difference in VAS Score on Postoperative Day 1

  before and after each stimulus for 10 minutes

Secondary Outcomes (8)

• The QoR-15 scale scores on the 1st and 3rd days after surgery

  1 day before the operation and the third day after the operation

• Postoperative Complication Rate

  1 day before being discharged from the hospital

• The time of the first postoperative anal exhaust

  On the third day after the operation

• The effective number of pain relief pump presses

  One day before being discharged from the hospital

• Postoperative Salvage Analgesic Consumption of Opioid Equivalents

  One day before being discharged from the hospital

Study Arms (2)

taVNS

EXPERIMENTAL

Set the pulse width to 200 microseconds, frequency to 30 Hz, and start the current at 10 mA. Gradually increase the current until the patient reaches their pain tolerance threshold, and cap it at 50 mA.

Device: taVNS

sham taVNS

SHAM COMPARATOR

Set the pulse width to 200 microseconds, frequency to 1 Hz, current to 10 mA and gradually increase it to the patient's pain tolerance threshold, capped at 50 mA.

Device: sham taVNS

Interventions

taVNS DEVICE

Set the pulse width to 200 microseconds, frequency to 30 Hz, and start the current at 10 mA. Gradually increase the current until the patient reaches their pain tolerance threshold, and cap it at 50 mA，last for one hour.During the intervention, dynamic ECG monitoring was conducted using an ECG monitor, starting 10 minutes before the stimulation and ending 10 minutes after the stimulation.

taVNS

sham taVNS DEVICE

Set the pulse width to 200 microseconds, frequency to 1 Hz, and start the current at 10 mA. Gradually increase the current until the patient reaches their pain tolerance threshold, and cap it at 50 mA，last for one hour.During the intervention, dynamic ECG monitoring was conducted using an ECG monitor, starting 10 minutes before the stimulation and ending 10 minutes after the stimulation.

sham taVNS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years, BMI 18-30 kg/m², ASA Ⅱ-Ⅲ, elective laparoscopic gastric or intestinal tumor surgery, expected surgical duration ≥2 hours, patient understands study content and signs informed consent form.

You may not qualify if:

• Kidney replacement therapy, treatment for arrhythmias requiring treatment, dementia, severe bradycardia, orthostatic tachycardia syndrome, neuro-muscular disorders, auricular dermatitis, planned post-operative transfer to ICU

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second affiliated Hospital School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: January 8, 2025
• Study Start: January 1, 2025
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 27, 2025

Record last verified: 2024-12

Locations

CN (1)