The Effect of taVNS on the Prognosis of Patients Undergoing Pancreatoduodenectomy

NCT ID: NCT06786923

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-08
• Study Completion Date: 2025-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Transcutaneous Auricular Vagus Nerve Stimulator

Intervention Type: DEVICE

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).

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients with other malignant tumors;
• Patients who have undergone chemotherapy or radiotherapy before surgery;
• Patients with chronic organ dysfunction;
• Patients with a history of gastrectomy or other gastric surgeries;
• Patients diagnosed with chronic gastrointestinal inflammation, peptic ulcers, or a history of gastroparesis, pyloric, or other gastrointestinal obstructions;
• Patients with a history of autonomic dysfunction (e.g., peripheral neuropathy, vagotomy, thyroid dysfunction, amyloidosis, asthma, heart failure, renal dysfunction, or alcoholism);
• Patients with implanted stimulators (e.g., pacemakers, implanted vagus nerve stimulators, deep brain stimulators, spinal cord stimulators), cochlear implants, or metallic implants (excluding dental work);
• Patients who recently used prokinetic agents, cholinergic or anticholinergic drugs, or hormones;
• Patients who received vagus nerve stimulation or acupuncture within 1 month before the study;
• Patients with skin damage or dermatological conditions at the stimulation site;
• Patients with a preoperative heart rate below 60 beats per minute;
• Patients unable to cooperate with assessments;
• Patients participating in other clinical trials.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Chaochao Zhong

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chao-Chao Zhong

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Nantong University

Locations

Affiliated hospital of Nantong University

Nantong, Jiangsu, China

Countries

China

Other Identifiers

2024-K265-02

Identifier Type: -

Identifier Source: org_study_id