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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous auricular vagus nerve stimulation (taVNS group) | Experimental | 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). |
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| Sham transcutaneous auricular vagus nerve stimulation (Sham taVNS group) | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulator | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| The first 7 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chao-Chao Zhong | Affiliated Hospital of Nantong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated hospital of Nantong University | Nantong | Jiangsu | 226001 | China |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| 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 | Up to 3 weeks postoperatively |
| Time to First Intake of Solid Food | The time to the first intake of solid food after surgery | Up to 3 weeks postoperatively |
| 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) | 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. | 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. | 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. | 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. | 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. | 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. | The first 48 hours postoperatively |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |