1. The goal of this clinical trial is to learn if transcutaneous electrical acupoint stimulation (TEAS), a non-invasive therapy that applies mild electrical current to specific points on the skin, can help patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) better tolerate the procedure and experience fewer complications related to sedation. It will also explore the underlying neuro-endocrine-immune mechanisms by measuring changes in serum biomarkers. 2. The main questions the study aims to answer are:
(1)Does TEAS reduce the incidence of sedation-related adverse events (such as low blood oxygen, low blood pressure, or breathing problems) during ERCP? (2)Does TEAS improve patient comfort and reduce the need for additional sedative medications during the procedure? (3)Does TEAS lead to faster recovery and higher patient and physician satisfaction? (4) Does TEAS modulate the neuro-endocrine-immune network, as reflected by changes in serum β-endorphin, cortisol, TNF-α, and IL-6 levels?
3.Researchers will compare two approaches:
1. Active TEAS: Electrical stimulation at specific points on the legs and arms before and during ERCP. 2. Sham TEAS: Pads placed on the same points but no electrical stimulation delivered (the device appears active).
4.All participants will receive standard conscious sedation with meperidine and diazepam, which is commonly used for ERCP in many centers. Participants will be randomly assigned to one of the two groups. The study will measure sedation-related complications, pain levels, medication requirements, recovery times, satisfaction scores, and changes in serum biomarkers (β-endorphin, cortisol, TNF-α, IL-6).
Patients aged 18-85 years scheduled for elective diagnostic or therapeutic endoscopic retrograde cholangiopancreatography (ERCP) for pancreaticobiliary indications.
American Society of Anesthesiologists (ASA) physical status classification I, II, or III.
Body mass index (BMI) between 18 and 30 kg/m².
Willing and able to provide written informed consent.
Known allergy or contraindication to meperidine, diazepam, or any other medication used in the protocol.
Chronic use of benzodiazepines or opioids (regular use more than three times per week in the preceding three months).
Severe cardiopulmonary, hepatic, or renal dysfunction (e.g., New York Heart Association class III or IV heart failure, uncontrolled chronic obstructive pulmonary disease, estimated glomerular filtration rate <30 mL/min/1.73m², active liver disease).
Anticipated difficult airway (Mallampati score IV, mouth opening <3 cm, thyromental distance <6 cm).
Parallel
TEAS + Conscious Sedation
Other interventionParticipants receive real Transcutaneous Electrical Acupoint Stimulation (TEAS) delivered via surface electrodes bilaterally at four predefined acupoints: Neiguan (PC6), Xuehai (SP10), Yinlingquan (SP9), and Yanglingquan (GB34). Stimulation (dense-disperse wave, 2/10 Hz alternating frequency, intensity 2-10 mA adjusted to patient tolerance) begins 30 minutes before sedation induction and continues throughout the procedure and for 15 minutes after procedure completion. All participants receive standardized conscious sedation with intravenous meperidine (initial dose 0.5 mg/kg) and diazepam (initial dose 0.1 mg/kg), titrated to a Ramsay Sedation Scale score of 2-4. Supplementary diazepam (0.05 mg/kg) may be administered as needed by a blinded anesthesiologist.
Sham TEAS + Conscious Sedation
Other interventionParticipants receive sham TEAS. Electrodes are placed identically to the Active TEAS Group at the same four acupoints (PC6, SP10, SP9, GB34) using the same device, but no electrical current is delivered. The device appears active (indicator lights on) to maintain blinding. All participants are informed that they may or may not feel any sensation, which is normal. All participants receive standardized conscious sedation with intravenous meperidine (initial dose 0.5 mg/kg) and diazepam (initial dose 0.1 mg/kg), titrated to a Ramsay Sedation Scale score of 2-4. Supplementary diazepam (0.05 mg/kg) may be administered as needed by a blinded anesthesiologist.
Composite Incidence of Sedation-Related Adverse Events
The composite incidence of sedation-related adverse events occurring from the start of sedation until discharge from the post-anesthesia care unit, defined as the occurrence of any of the following: hypoxemia (SpO₂ \<90% for ≥10 seconds, or requirement for airway interventions including chin lift, jaw thrust, or bag-mask ventilation); hypotension (systolic blood pressure \<90 mmHg or a decrease of \>20% from baseline, or requirement for vasoactive drugs); respiratory depression (respiratory rate \<8 breaths per minute, or apnea for \>15 seconds); arrhythmias (new-onset bradycardia with heart rate \<50 bpm requiring treatment, tachycardia \>120 bpm, or any arrhythmia requiring pharmacological intervention).
Procedure Success Rate
Defined as successful cannulation of the desired duct (bile or pancreatic duct) and completion of the intended diagnostic or therapeutic intervention.
Total Dose of Sedatives and Analgesics
Meperidine and diazepam total dosage (mg).
Mean Arterial Pressure (MAP)
Mean arterial pressure (MAP) measured in mmHg at the following time points: baseline, after sedation, at scope insertion, every 5 minutes during the procedure, at end of procedure, and at post-anesthesia care unit (PACU) discharge. Multiple measurements over time will be summarized as the mean of all intra-procedural measurements for each participant, and group-level comparisons will be performed using a linear mixed model.
Heart Rate (HR)
Heart rate (HR) measured in beats per minute (bpm) at the following time points: baseline, after sedation, at scope insertion, every 5 minutes during the procedure, at end of procedure, and at post-anesthesia care unit (PACU) discharge. Multiple measurements over time will be summarized as the mean of all intra-procedural measurements for each participant, and group-level comparisons will be performed using a linear mixed model.
Change in Serum β-endorphin Level
Change from baseline (before TEAS/sham initiation) to 2 hours post-ERCP completion. Measured by high-sensitivity ELISA kit.
Change in Serum Cortisol Level
Change from baseline (before TEAS/sham initiation) to 2 hours post-ERCP completion. Measured by high-sensitivity ELISA kit.
Change in Serum TNF-α Level
Change from baseline (before TEAS/sham initiation) to 2 hours post-ERCP completion. Measured by high-sensitivity ELISA kit.
Change in Serum IL-6 Level
Change from baseline (before TEAS/sham initiation) to 2 hours post-ERCP completion. Measured by high-sensitivity ELISA kit.
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