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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
84
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).
Affiliated hospital of Nantong University
Nantong, Jiangsu, China
Incidence of Postoperative Delayed Gastric Emptying
The definition of delayed gastric emptying (DGE) after pancreatic surgery, as suggested by the International Study Group of Pancreatic Surgery (ISGPS), is as follows: Excluding mechanical factors such as intestinal obstruction and anastomotic stricture, DGE can be diagnosed if any of the following conditions are met: 1. The need for nasogastric tube placement persists for more than 3 days postoperatively. 2. Re-insertion of the nasogastric tube is required due to vomiting or other reasons after its removal. 3. The patient is unable to consume solid food 7 days postoperatively.
Time frame: The first 7 days postoperatively
Incidence of Grade A, B, and C Postoperative Delayed Gastric Emptying
Based on the severity of postoperative delayed gastric emptying (DGE) following pancreatic surgery, DGE is classified into three grades: A, B, and C: Grade A: Requires nasogastric tube placement from postoperative days 4 to 7 or re-insertion of the tube after 3 days. Patients are unable to tolerate oral solid food for more than 7 days postoperatively. Grade B: Requires nasogastric tube placement from postoperative days 8 to 14 or re-insertion of the tube after 7 days. Patients are unable to tolerate oral solid food for more than 14 days postoperatively. Grade C: Nasogastric tube cannot be removed within 14 days postoperatively or requires re-insertion after 14 days. Patients are unable to tolerate oral solid food for more than 21 days postoperatively.
Time frame: The first 21 days postoperatively
Duration of Nasogastric Tube Drainage After Surgery
The time from the end of surgery to the first removal of the nasogastric tube
Time frame: Up to 3 weeks postoperatively
Time to First Intake of Solid Food
The time to the first intake of solid food after surgery
Time frame: Up to 3 weeks postoperatively
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Incidence of Other Postoperative Complications Following Pancreatic Surgery (Including Pancreatic Fistula, Bile Leakage, Chylous Fistula, Postoperative Bleeding, and Abdominal Infection)
Incidence of other postoperative complications after pancreatic surgery (such as pancreatic fistula, bile leak, chyle leak, postoperative bleeding, and intra-abdominal infection)
Time frame: Up to 5 weeks postoperatively
Severity of Postoperative Complications (Assessed Using the Clavien-Dindo Classification System)
The severity of postoperative complications (assessed using the Clavien-Dindo classification) refers to a system that classifies postoperative complications based on their severity. The Clavien-Dindo classification system is a widely used standardized method in clinical practice, designed to help doctors objectively assess the severity of postoperative complications, providing a basis for clinical management and research.The system classifies postoperative complications into five levels based on severity, ranging from Grade I (mildest) to Grade V (most severe). Each grade represents the impact of the complication on the patient and the degree of treatment required.
Time frame: Up to 5 weeks postoperatively
Total Length of Hospital Stay
The total length of hospital stay refers to the entire duration of the patient's hospitalization from admission to discharge.
Time frame: Up to 5 weeks postoperatively
NRS Score Measured on the Day Before Surgery, and Postoperative Days 1, 3, and 7
The NRS (Numerical Rating Scale) is used to assess the intensity of pain.The higher the score, the more severe the pain.
Time frame: Preoperative Day 1, Postoperative Day 1, 3, 7
Hospital Anxiety and Depression Scale (HADS) Before Surgery and on Postoperative Days 7 and 14
The Hospital Anxiety and Depression Scale (HADS) is used to evaluate the severity of anxiety and depression in individuals.
Time frame: Preoperative Day 1, Postoperative Day 7, 14
PROMIS SD-SF 8a Assessment on Preoperative and Postoperative Days 7 and 14
The Patient-Reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8a (PROMIS SD-SF 8a) is an 8-item self-reported questionnaire developed by the Patient-Reported Outcomes Measurement Information System to assess sleep disturbance over the past 7 days. It evaluates aspects such as difficulty falling asleep, sleep maintenance, sleep quality, and daytime functioning, providing a standardized measure of sleep disturbance severity.
Time frame: Preoperative Day 1, Postoperative Day 7, 14
Incidence of Postoperative Nausea and Vomiting (PONV) within 48 Hours
To determine the incidence of postoperative nausea and vomiting (PONV) within 48 hours.
Time frame: The first 48 hours postoperatively