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

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 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).

Conditions

• Endoscopic Retrograde Cholangiopancreatography
• Conscious Sedation Adverse Event
• Procedural Pain
• Sedation-related Complications

Interventions

OTHER

TEAS + Conscious Sedation

Participants 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.

OTHER

Sham TEAS + Conscious Sedation

Participants 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.

Sponsors & Collaborators

• Beijing 302 Hospital

  lead OTHER

Principal Investigators

• Liang Zheng, Doctor · Beijing 302 Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-08-31

Completion

2027-10-01

Countries

• China

Study Locations