TEAS for Sedation During ERCP: A Multicenter Trial (TEAS-ERCP-MC)

Transcutaneous Electrical Acupoint Stimulation Combined With Traditional Conscious Sedation for Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Sham-Controlled, Multicenter Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Endoscopic Retrograde Cholangiopancreatography; Procedural Pain; Sedation-related Complications; Conscious Sedation Adverse Event
• Intervention / Treatment: Other: TEAS + Conscious Sedation; Other: Sham TEAS + Conscious Sedation

Detailed Description

1. Background and Rationale:

   Endoscopic retrograde cholangiopancreatography (ERCP) is a complex procedure essential for diagnosing and treating various pancreaticobiliary disorders. Adequate sedation is critical for patient comfort and procedural success. Traditional conscious sedation with meperidine and diazepam remains widely used, particularly in resource-limited settings, but is associated with risks of respiratory depression, hypoxemia, hypotension, and inadequate sedation.

   Transcutaneous electrical acupoint stimulation (TEAS) is a non-invasive modality derived from traditional acupuncture principles that delivers controlled electrical currents to specific acupoints via surface electrodes. TEAS has been shown to exert analgesic effects through the release of endogenous opioid peptides, modulate autonomic nervous system function, reduce perioperative opioid requirements, and decrease the incidence of postoperative nausea and vomiting.

   However, robust evidence on its efficacy and safety specifically during ERCP with traditional conscious sedation is lacking. This multicenter trial aims to rigorously evaluate whether adjunctive TEAS improves procedural safety, tolerance, and clinical outcomes in patients undergoing ERCP.

2. Study Design and Methodology:

This is a prospective, randomized, sham-controlled, single-blind, parallel-group, multicenter trial conducted at three centers: Fifth Medical Center (lead site), First Medical Center, and Third Medical Center of Chinese PLA General Hospital.

Patients scheduled for elective diagnostic or therapeutic ERCP will be assessed for eligibility. Eligible and consenting participants will be randomly assigned (1:1) using a computer-generated random allocation sequence with permuted blocks of variable sizes (4 and 6), with allocation concealment in sequentially numbered, opaque, sealed envelopes.

Participants will be allocated to one of two groups:

1. Active TEAS Group: Receives real TEAS stimulation applied bilaterally to four predefined acupoints: Yinlingquan (SP9), Yanglingquan (GB34), Xuehai (SP10), and Neiguan (PC6). Acupoint locations will be determined according to WHO Standard Acupuncture Point Locations. Disposable self-adhesive electrodes (diameter 3 cm) will be connected to a Hwato SDZ-III electronic acupoint stimulator (Suzhou Medical Supplies Factory Co., Ltd., China). Stimulation parameters are set to dense-disperse wave mode (alternating frequencies of 2 Hz and 20 Hz, each for 3 seconds). The intensity is adjusted to the patient's maximum tolerable level (typically 2-5 mA). Stimulation begins 30 minutes before the procedure and continues throughout the endoscopic procedure.
2. Sham TEAS Group: Receives identical electrode placement at the same four bilateral acupoints using the same device, but no electrical current is delivered. The device appears active (indicator lights on) to maintain blinding. All patients in both groups are informed that they may or may not feel any sensation during the stimulation, which is normal.
3. Standardized Sedation Protocol (Both Groups): All participants receive standardized conscious sedation with intravenous meperidine (0.5 mg/kg) and diazepam (0.1 mg/kg) administered by an anesthesiologist or trained physician blinded to group assignment. Additional doses of diazepam (1/3 to 1/2 of initial dose) may be administered if needed based on patient response and Ramsay Sedation Scale (target score 2-4). ERCP procedures are performed by experienced gastroenterologists (each with >300 prior ERCPs) who are also blinded to group assignment. A designated research assistant who is not involved in patient care, outcome assessment, or data analysis performs the TEAS or sham-TEAS intervention and ensures that the device display is shielded from the patient's view.
4. Blinding: A designated research assistant not involved in patient care, outcome assessment, or data analysis performs the TEAS or sham-TEAS intervention. The device display is shielded from the patient's view. Patients, endoscopists, outcome assessors, and data analysts are blinded to group assignment.

3.Sample Size Calculation: Based on the primary outcome measure (Visual Analogue Scale, VAS score), assuming a mean difference of 2.0 points between groups, a standard deviation of 3.0, α=0.05 (two-sided), and β=0.20 (80% power), the calculated sample size is approximately 36 patients per group. Considering potential dropouts (10-15%) and the need for subgroup analyses, the final sample size is set at 65 patients per group, for a total of 130 patients across all three centers. Sample size allocation will be balanced across centers (approximately 22 patients per group per center).

4.Statistical Analysis Plan:

1. Descriptive Statistics: Continuous variables: mean ± standard deviation (SD) if normally distributed, or median with interquartile range (IQR) if non-normally distributed. Categorical variables: frequencies and percentages (n, %).

   Baseline Comparability.

2. Continuous variables: one-way analysis of variance (ANOVA) or Kruskal-Wallis test. Categorical variables: χ² test or Fisher's exact test.
3. Primary Outcome Analysis:The composite incidence of sedation-related adverse events will be compared between groups using χ² test. Center stratification will be performed using Cochran-Mantel-Haenszel test to account for potential center effects.
4. Secondary Outcome Analysis: Continuous variables (sedative doses, VAS scores, recovery time, discharge time): independent samples t-test for normally distributed data, Mann-Whitney U test for non-normally distributed data. Repeated measures (MAP, HR at multiple time points): repeated measures ANOVA or generalized estimating equations (GEE). Categorical variables (satisfaction scores, adverse events): χ² test or Fisher's exact test.
5. Multivariable Analysis: Binary logistic regression: factors influencing sedation success rate and adverse events, including covariates such as age, sex, BMI, ASA class, center, procedure type, and medication dosage. Multiple linear regression: factors influencing VAS score, recovery time, and discharge time, including the same covariates.
6. Center Effect: Heterogeneity across centers will be assessed using Cochran-Mantel-Haenszel test. If significant heterogeneity is detected, generalized linear mixed models (GLMM) with center as random effect will be used.
7. Statistical Software and Significance Level: SPSS version 27.0 or R software (version 4.0 or higher). Two-sided tests with significance level α=0.05; P < 0.05 considered statistically significant.

5.Scientific Justification: The selection of specific acupoints (SP9, GB34, SP10, PC6) is based on traditional Chinese medicine principles and modern physiological understanding: targeting points associated with visceral analgesia (GB34, SP9), gastrointestinal motility regulation and anti-emesis (PC6, ST36-like effects), and calming effects (PC6). The sham-controlled design is crucial for isolating the specific effects of electrical neuromodulation from non-specific placebo effects. This trial addresses a significant gap in optimizing sedation for ERCP by evaluating a readily deployable, non-pharmacological adjunctive strategy that could enhance patient safety and procedural quality, particularly in settings where newer sedative agents or dedicated anesthesia services are not readily available.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zheng Lu, Doctor; Phone Number: +86 10 18800153001; Email: wuliangdoc@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100039
      • Recruiting
      • The Fifth Medical Center of PLA General Hospital
      • Contact: Zheng Lu, Doctor; Phone Number: +86 10 18800153001; Email: wuliangdoc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

1. Inclusion Criteria:

1. Patients aged 18-80 years scheduled for elective diagnostic or therapeutic endoscopic retrograde cholangiopancreatography (ERCP) for pancreaticobiliary indications.
2. American Society of Anesthesiologists (ASA) physical status classification I, II, or III.
3. Body mass index (BMI) between 18 and 30 kg/m².
4. Willing and able to provide written informed consent.

2. Exclusion Criteria:

1. Known allergy or contraindication to meperidine, diazepam, or any other medication used in the protocol.
2. Chronic use of benzodiazepines or opioids (regular use more than three times per week in the preceding three months).
3. 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).
4. Anticipated difficult airway (Mallampati score IV, mouth opening <3 cm, thyromental distance <6 cm).
5. Untreated or severe obstructive sleep apnea requiring continuous positive airway pressure therapy.
6. Pregnancy or breastfeeding.
7. Psychiatric or cognitive disorders precluding cooperation or valid assessment (e.g., severe anxiety, cognitive impairment).
8. Pre-induction resting heart rate <50 beats per minute or second-degree or higher atrioventricular block.
9. Conditions predisposing to aspiration (e.g., gastric outlet obstruction, previous esophageal or gastric surgery with delayed emptying).
10. Previous exposure to transcutaneous electrical acupoint stimulation or knowledge of TEAS that could compromise blinding for the sham procedure.
11. Skin lesions, infections, or electronic implants at or near the proposed acupoint locations.
12. Inability to provide informed consent.

3. Dropout Criteria:

1. Requirement for conversion to general anesthesia due to failed sedation or clinical necessity.
2. Occurrence of a serious adverse event related to the study intervention (e.g., severe allergic reaction, hemodynamic collapse).
3. Life-threatening deterioration during endoscopy (e.g., uncontrolled bleeding, respiratory failure, cardiac arrest).
4. Voluntary withdrawal of consent by participant or legal representative at any time.
5. Occurrence of a major ERCP-related complication (e.g., perforation, major bleeding, severe pancreatitis) requiring surgical or intensive care intervention.
6. Principal investigator-identified safety risks (e.g., sepsis, acute liver failure).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active TEAS + Conscious Sedation; 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 and for 15 minutes after procedure completion. All participants receive standardized conscious sedation with intravenous meperidine (0.5 mg/kg) and diazepam (0.1 mg/kg) administered by a blinded anesthesiologist.	Other: TEAS + Conscious Sedation; 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.
Sham Comparator: Sham TEAS + Conscious Sedation; 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.	Other: Sham TEAS + Conscious Sedation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Incidence of Sedation-Related Adverse Events	The composite incidence of sedation-related adverse events occurring from the start of sedation until discharge from the post-anesthesia care unit, defined as the occurrence of any of the following: hypoxemia (SpO₂ <90% for ≥10 seconds, or requirement for airway interventions including chin lift, jaw thrust, or bag-mask ventilation); hypotension (systolic blood pressure <90 mmHg or a decrease of >20% from baseline, or requirement for vasoactive drugs); respiratory depression (respiratory rate <8 breaths per minute, or apnea for >15 seconds); arrhythmias (new-onset bradycardia with heart rate <50 bpm requiring treatment, tachycardia >120 bpm, or any arrhythmia requiring pharmacological intervention).	From start of sedation until discharge from post-anesthesia care unit (approximately 1-3 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Success Rate	Defined as successful cannulation of the desired duct (bile or pancreatic duct) and completion of the intended diagnostic or therapeutic intervention.	Immediately after the endoscopy procedure
Pain Score During Ampullary Cannulation	Assessed using a 10-point Visual Analogue Scale (VAS, 0 = no pain, 10 = worst pain imaginable) at the time of ampullary cannulation.	During ampullary cannulation
Pain Score at 30 Minutes Post-Procedure	Assessed using a 10-point Visual Analogue Scale (VAS, 0 = no pain, 10 = worst pain imaginable) at 30 minutes after procedure completion.	30 minutes post-procedure
Sedation Depth During Ampullary Cannulation	Assessed using the 6-point Ramsay Sedation Scale (1 = anxious, agitated; 2 = cooperative, tranquil; 3 = drowsy but responds to commands; 4 = asleep but brisk response to glabellar tap; 5 = asleep with sluggish response; 6 = no response) at the time of ampullary cannulation.	During ampullary cannulation
Endoscopist Satisfaction	Assessed by the performing gastroenterologist immediately after the procedure using a 5-point Likert scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied).	Immediately after the endoscopy procedure
Patient Satisfaction	Assessed by the patient at the time of post-anesthesia care unit discharge using a 5-point Likert scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied).	At post-anesthesia care unit discharge (approximately 1-2 hours post-procedure)
Incidence of Postoperative Nausea and Vomiting (24 Hours)	Incidence of nausea or vomiting within 24 hours post-procedure, assessed by patient report and nursing records.	Within 24 hours post-procedure
Incidence of Post-ERCP Pancreatitis	Defined by consensus criteria (new or worsened abdominal pain, serum amylase or lipase ≥3 times normal at >24 hours post-procedure, and imaging findings consistent with pancreatitis).	Within 24 hours post-procedure
Total Dose of Sedatives	Meperidine and diazepam total dosage (mg)	Immediately after procedure

Collaborators and Investigators

• Sponsor: Beijing 302 Hospital
• Investigators: Principal Investigator: Liang Zheng, Doctor, Beijing 302 Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Acupuncture; ERCP; Diazepam; Conscious Sedation; Transcutaneous Electrical Acupoint Stimulation; Non-Pharmacological Intervention; Sedation-Related Adverse Events
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Procedural; Anesthesia and Analgesia; Conscious Sedation
• Other Study ID Numbers: 2025-TEAS-ERCP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Ongoing Research Commitments: Further analyses and secondary studies using the same dataset are planned, including subgroup investigations and long-term outcome assessments. Premature data sharing could compromise the integrity of these planned works.; Participant Privacy and Confidentiality: The dataset contains sensitive clinical information. Complete anonymization is challenging, and re-identification risks violate ethical and legal safeguards established by the institutional ethics committee and relevant regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No