An interventional study of taVNS and sham taVNS in taVNS, Gastrointestinal Tumor Surgery and Visual Analogue Scale, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-27.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
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.
Subjects who met the inclusion criteria were enrolled in the clinical trial and received 2 interventions at the following times: the day before surgery, and the afternoon of the 1st day postoperatively (15:00-17:00), a total of 2 times. The intervention implementers used vagus nerve stimulation equipment to place electrodes in the tragus area of the outer ear of the subjects in the experimental group (taVNS group). The control group (sham stimulation group) was set to have a pulse width of 200 μs, a frequency of 1 Hz, and an initial current of 10 mA, which was gradually increased to the pain tolerance threshold of the subject, capped at 50 mA，last for one hour. The VAS scores before and after stimulation for 10 minutes were recorded.
2) ECG monitoring: Both groups were monitored with a dynamic ECG monitor during the intervention period, starting 10 minutes before stimulation and ending 10 minutes after stimulation. The SDNN (Standard Deviation of NN intervals) of the sinus rhythm was measured before and after stimulation for 10 minutes. A uniform standard was used for anesthesia induction and maintenance during surgery, and all patients used the same patient-controlled intravenous analgesia (PCIA) plan.
Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
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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.
Exclusion Criteria:
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
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
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
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.
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.
Difference in VAS Score on Postoperative Day 1
Difference in VAS Score on Postoperative Day 1
Time frame: before and after each stimulus for 10 minutes
The QoR-15 scale scores on the 1st and 3rd days after surgery
The QoR-15 scale scores on the 1st and 3rd days after surgery
Time frame: 1 day before the operation and the third day after the operation
Postoperative Complication Rate
Postoperative in-hospital complication rate
Time frame: 1 day before being discharged from the hospital
The time of the first postoperative anal exhaust
The time of the first postoperative anal exhaust
Time frame: On the third day after the operation
The effective number of pain relief pump presses
The effective number of pain relief pump presses
Time frame: One day before being discharged from the hospital
Postoperative Salvage Analgesic Consumption of Opioid Equivalents
Postoperative Salvage Analgesic Consumption of Opioid Equivalents
Time frame: One day before being discharged from the hospital
Length of hospital stay
Length of hospital stay
Time frame: One day before being discharged from the hospital
Standard Deviation of NN intervals
10 minutes before and after each stimulus
Time frame: 10 minutes before and after each stimulus
Root Mean Square of the Successive Differences
10 minutes before and after each stimulus
Time frame: 10 minutes before and after each stimulus
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University