Actively Recruiting
Transcutaneous Electrical Acupoint Stimulation Combined With Traditional Conscious Sedation for Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Sham-Controlled, Multicenter Trial
Led by Beijing 302 Hospital · Updated on 2026-03-24
130
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether transcutaneous electrical acupoint stimulation (TEAS), a non-invasive therapy applying mild electrical current to specific skin points, can improve patient tolerance and reduce sedation-related complications during endoscopic retrograde cholangiopancreatography (ERCP). The study aims to determine if TEAS reduces sedation adverse events, improves comfort, decreases sedative medication needs, and enhances recovery and satisfaction. This multicenter, randomized, sham-controlled trial compares active TEAS with sham TEAS alongside standard sedation. Participants will be randomly assigned to receive either active TEAS, with electrical stimulation applied bilaterally to four acupoints on the legs and arms starting 30 minutes before and continuing throughout ERCP, or sham TEAS with electrodes placed similarly but no current delivered. Both groups receive standard conscious sedation with meperidine and diazepam. The TEAS device is managed by a blinded research assistant, and all care providers and patients are blinded to group assignment. During the study, participants will undergo the ERCP procedure with sedation, while researchers monitor sedation-related adverse events from sedation start until post-anesthesia care unit discharge (approximately 1-3 hours). They will assess pain, sedative doses, recovery times, and satisfaction from patients and endoscopists. Safety is closely observed, and data analysis includes comparisons of adverse events, procedural success, and patient comfort. Total participation includes the procedure and immediate recovery period, with follow-up assessments for complications within 24 hours.
CONDITIONS
Brief 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 ERCP for pancreaticobiliary conditions
- American Society of Anesthesiologists (ASA) physical status I, II, or III
- Body mass index (BMI) between 18 and 30 kg/m8
- Willing and able to provide written informed consent
You will not qualify if you...
- Known allergy or contraindication to meperidine, diazepam, or other study medications
- Chronic use of benzodiazepines or opioids (more than three times per week in the last three months)
- Severe heart, lung, liver, or kidney dysfunction (e.g., advanced heart failure, uncontrolled COPD, liver disease)
- Anticipated difficult airway (specific anatomical criteria)
- Untreated or severe obstructive sleep apnea requiring CPAP
- Pregnancy or breastfeeding
- Psychiatric or cognitive disorders that prevent cooperation or valid assessment
- Low resting heart rate (<50 bpm) or atrioventricular block of second degree or higher
- Conditions increasing risk of aspiration (e.g., gastric outlet obstruction, prior surgeries affecting emptying)
- Previous exposure to TEAS or knowledge that could affect blinding
- Skin lesions, infections, or electronic implants near acupoint sites
- Inability to provide informed consent or voluntary withdrawal
- Serious adverse events or complications requiring surgery or intensive care during the study
- Investigator-identified safety risks such as sepsis or acute liver failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day (procedure day)
Participants receive either real or sham Transcutaneous Electrical Acupoint Stimulation (TEAS) starting 30 minutes before and continuing throughout the ERCP procedure along with standardized conscious sedation using intravenous meperidine and diazepam administered by a blinded anesthesiologist.
1 procedure visit (in-person)
Duration - Up to 24 hours post-procedure
Participants are monitored for sedation-related adverse events and recovery until discharge from the post-anesthesia care unit and for postoperative outcomes including nausea, vomiting, and pancreatitis up to 24 hours post-procedure.
1 post-procedure visit (in-person)
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
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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