Using TEAS to reduce sedation-related complications during ERCP

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

This trial will test whether adding non-invasive TEAS to standard conscious sedation helps adults having ERCP tolerate the procedure better and have fewer sedation-related complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing 302 Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07440342 on ClinicalTrials.gov

What this trial studies

This randomized, sham-controlled, single-blind, parallel-group multicenter trial compares active transcutaneous electrical acupoint stimulation (TEAS) plus standard conscious sedation versus sham TEAS plus standard conscious sedation in adults undergoing ERCP. Eligible patients are 18–80 years old with ASA physical status I–III and BMI 18–30 kg/m² who are scheduled for elective diagnostic or therapeutic ERCP. TEAS is applied to specific arm and leg acupoints before and during the procedure while outcomes are recorded by blinded assessors. Primary outcomes include sedation-related adverse events, need for additional sedatives, procedural success, recovery time, and patient and physician satisfaction.

Who should consider this trial

Good fit: Adults aged 18–80 scheduled for elective diagnostic or therapeutic ERCP with ASA I–III, BMI 18–30, and able to give informed consent are the ideal candidates.

Not a fit: Patients with severe cardiopulmonary, hepatic, or renal dysfunction, chronic opioid or benzodiazepine use, allergies to the sedation medications, or an anticipated difficult airway are excluded and unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, TEAS could lower the rate of sedation-related breathing and blood pressure problems during ERCP and reduce the need for extra sedative medications.

How similar studies have performed: TEAS and related transcutaneous acupuncture methods have shown perioperative analgesic effects and reduced opioid needs in other surgical settings, but application specifically during ERCP with conscious sedation is novel and not yet proven.

Eligibility criteria

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).

Where this trial is running

Beijing, Beijing Municipality

• The Fifth Medical Center of PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Liang Zheng, Doctor — Beijing 302 Hospital
• Study coordinator: Zheng Lu, Doctor

Conditions Endoscopic Retrograde Cholangiopancreatography; Conscious Sedation Adverse Event; Procedural Pain; Sedation-related Complications; Transcutaneous Electrical Acupoint Stimulation; ERCP; Conscious Sedation; Diazepam