TEAS for Sedation During ERCP: A Multicenter Trial
Transcutaneous Electrical Acupoint Stimulation Combined With Traditional Conscious Sedation for Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Sham-Controlled, Multicenter Trial
Beijing 302 Hospital
130 participants
Jan 1, 2025
INTERVENTIONAL
Conditions
Summary
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 test whether TEAS improves procedural success and patient satisfaction. 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? 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, and satisfaction scores.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Participants receive real Transcutaneous Electrical Acupoint Stimulation (TEAS) delivered via surface electrodes bilaterally at four predefined acupoints: Yinlingquan (SP9), Yanglingquan (GB34), Xuehai (SP10), and Neiguan (PC6). Stimulation (dense-disperse wave, 2/20 Hz alternating frequency, intensity 2-5 mA adjusted to patient tolerance) begins 30 minutes before ERCP and continues throughout the procedure. All participants receive standardized conscious sedation with intravenous meperidine (0.5 mg/kg) and diazepam (0.1 mg/kg) administered by a blinded anesthesiologist.
Participants receive sham TEAS. Electrodes are placed identically to the Active TEAS Group at the same four acupoints (SP9, GB34, SP10, PC6) 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 identical standardized conscious sedation with intravenous meperidine (0.5 mg/kg) and diazepam (0.1 mg/kg) administered by a blinded anesthesiologist.
Locations(1)
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NCT07440342