TEAS for Sedation During ERCP: A Multicenter Trial With Mechanistic Substudy

Starting soon · Not applicable · Has a placebo group

Conditions studied: Endoscopic Retrograde Cholangiopancreatography, Conscious Sedation Adverse Event, Procedural Pain, Sedation-related Complications

In brief

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).

Key facts

Study ID
NCT07440342
Run by
Beijing 302 Hospital
People needed
130
Starts
2026-09-01
Expected to finish
2027-10-01
Last updated by the study team
2026-06-16

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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