NCT06786923

The Effect of taVNS on the Prognosis of Patients Undergoing Pancreatoduodenectomy

The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on the Incidence of Delayed Gastric Emptying After Pancreatoduodenectomy: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To explore the effects of transcutaneous auricular vagus nerve stimulation (taVNS) during the perioperative period on the incidence of delayed gastric emptying after pancreatoduodenectomy and its possible mechanisms.

Detailed description

Patients are recruited one week prior to the start of the trial, during which they are informed about the experimental protocol and associated risks. After obtaining informed consent and signatures, they are enrolled as study participants. Patients who meet the trial criteria are randomly assigned in a 1:1 ratio to the control group (sham taVNS group) and the intervention group (taVNS group, with taVNS intervention starting 30 minutes prior to anesthesia induction and continuing until the end of surgery, terminating after the removal of the endotracheal tube in the PACU), in a double-blind manner (with taVNS intervention and postoperative follow-up conducted by different researchers).

Conditions

• Delayed Gastric Emptying

Interventions

Type	Name	Description
DEVICE	Transcutaneous Auricular Vagus Nerve Stimulator	Intervention Timing of Transcutaneous Auricular Vagus Nerve Stimulator: The intervention will begin 30 minutes before anesthesia induction and continue until the end of the surgery, terminating after the removal of the endotracheal tube in the PACU. The stimulation parameters are set as follows: frequency 25 Hz, pulse width 200 μs, 30 seconds on / 30 seconds off, with the current intensity set to the maximum amplitude the patient can tolerate (just below the pain threshold).

Timeline

• Start date: 2025-01-08
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2025-01-22
• Last updated: 2025-11-18

Locations

1 site across 1 country: China