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

Zhejiang University

Status: Completed

Conditions: Gastrointestinal Tumor Surgery; Visual Analogue Scale; taVNS; Complications

Treatments: Device: sham taVNS; Device: taVNS

Study type: Interventional

Funder types: Other

Identifiers

NCT06763913

2024-1127

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

taVNS

Experimental group

Description:

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.

Treatment:

Device: taVNS

sham taVNS

Sham Comparator group

Description:

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.

Treatment:

Device: sham taVNS