Actively Recruiting
TEAS for Sedation During ERCP: A Multicenter Trial
Led by Beijing 302 Hospital · Updated on 2026-03-24
130
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TEAS for Sedation During ERCP: A Multicenter Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18-80 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.
You will not qualify if you...
- 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).
- Untreated or severe obstructive sleep apnea requiring continuous positive airway pressure therapy.
- Pregnancy or breastfeeding.
- Psychiatric or cognitive disorders precluding cooperation or valid assessment (e.g., severe anxiety, cognitive impairment).
- Pre-induction resting heart rate <50 beats per minute or second-degree or higher atrioventricular block.
- Conditions predisposing to aspiration (e.g., gastric outlet obstruction, previous esophageal or gastric surgery with delayed emptying).
- Previous exposure to transcutaneous electrical acupoint stimulation or knowledge of TEAS that could compromise blinding for the sham procedure.
- Skin lesions, infections, or electronic implants at or near the proposed acupoint locations.
- Inability to provide informed consent.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China, 100039
Actively Recruiting
Research Team
Z
Zheng Lu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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