The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on the Incidence of Delayed Gastric Emptying After Pancreatoduodenectomy: A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years;
• Diagnosed with pancreatic tumors or periampullary tumors by imaging or pathology and scheduled for pancreaticoduodenectomy;
• No distant metastases and tumors are resectable;
• Classified as American Society of Anesthesiologists (ASA) physical status I to III;
• Capable of understanding the study procedures and various assessment scales and able to effectively communicate with the researchers;
• Willing to participate in the study and provide written informed consent.
Locations
Other Locations
China
Affiliated hospital of Nantong University
RECRUITING
Nantong
Contact Information
Primary
Chao-Chao Zhong, M.D.;P.h.D
zhong249767626@163.com
15152460489
Time Frame
Start Date: 2025-01-08
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 84
Treatments
Experimental: Transcutaneous auricular vagus nerve stimulation (taVNS group)
Patients in the taVNS group will have a transcutaneous auricular vagus nerve stimulation device with a transparent, non-insulated thin film placed on the cymba conchae of the left ear. TaVNS will be administered on the day of surgery (starting 30 minutes before anesthesia induction and continuing 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).
No_intervention: Sham transcutaneous auricular vagus nerve stimulation (Sham taVNS group)
Patients in the Sham taVNS group will have a transcutaneous auricular vagus nerve stimulation device with a transparent insulating film placed on the cymba conchae of the left ear on the day of surgery. The stimulation parameters, method, and duration will be the same as those in the taVNS group. However, due to the insulating film applied to the stimulation device in the sham group, patients will not actually receive any stimulation.
Related Therapeutic Areas
Sponsors
Leads: Affiliated Hospital of Nantong University