Biliary calculi
Conditions
Interventions
Group T:Preoperatively, patients will undergo transcutaneous auricular vagus nerve stimulation (taVNS) applied to the left tragus or cymba conchae, delivered at 25 Hz with a 200 µs pulse width and 1–2
Group S:The patient underwent stimulation in the area of the left pinna or ear conch before the procedure, with parameters of pulse width of 200 µs, frequency of 0 Hz (no actual current output), and a
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Age 18–80 years, any sex. Scheduled to undergo elective ERCP under general anesthesia with endotracheal intubation. ASA physical status I–III. No hearing, speech, or cognitive impairments; able to complete 24-hour postoperative follow-up. Able to clearly understand the study and willing to provide written informed consent. No evident autonomic dysfunction on preoperative assessment prior to the intervention. BMI 18.5–28 kg/m² (to exclude extreme body habitus that may confound autonomic function). Not concurrently receiving other interventions that could affect postoperative nausea and vomiting (PONV) or gastrointestinal function (e.g., acupuncture, other neuromodulatory therapies). No use of sedatives, antiemetics, or other medications likely to affect autonomic or gastrointestinal function within 72 hours before the procedure.
Exclusion criteria
Exclusion criteria: 1. Lesions, trauma, or prior surgery of the oropharynx/larynx that could confound assessment of cough/gag reflex and postoperative sore throat. 2. History of postoperative nausea and vomiting (PONV) or motion sickness; or concomitant central nervous system disease. 3. Severe gastrointestinal diseases (e.g., gastric cancer, esophageal cancer). 4. Auricular inflammation, external auditory canal infection, or anatomical variations that preclude proper electrode placement. 5. Diagnosed vagal dysfunction, autonomic neuropathy, or severe dysautonomia. 6. Known hypersensitivity to electrical stimulation or to electrode/adhesive materials. 7. Current use of, or use within the past month of, medications that may affect autonomic function (e.g., antiemetics, anticholinergics, antidepressants, antiepileptic drugs). 8. Presence of a cardiac pacemaker, implantable cardioverter-defibrillator (ICD), or other implanted electronic device. 9. Severe hepatic or renal impairment; significant cardiovascular or cerebrovascular disease; epilepsy or other major neurologic disorders. 10. Severe anxiety, depression, or other psychiatric disorders that would preclude cooperation with the intervention and outcome assessments. 11. Pregnant or lactating women (preoperative pregnancy-exclusion declaration required). 12. Participation in another clinical trial within the previous 3 months. 13. Any other condition that, in the investigator's judgment, renders the patient unsuitable for study participation (e.g., major life events, communication barriers).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gastrointestinal functional recovery; | — |
Secondary
| Measure | Time frame |
|---|---|
| General patient information: age, gender, BMI, ASA classification, etc.;Parasympathetic response during surgery.;Incidence of PONV and treatment options.;HRV parameters (LF/HF, RMSSD).;Levels of inflammatory factors (IL-6, TNF-a) 2 hours and 24 hours post-surgery.;Incidence of adverse events following ERCP (pancreatitis, bleeding, cholangitis, cholecystitis, etc.); | — |
Countries
China
Contacts
Public ContactHu Xianwen
The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed