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NCT07440342

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

Sponsor: Beijing 302 Hospital

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2026-09-01

Completion Date

2027-10-01

Last Updated

2026-06-16

Healthy Volunteers

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.

1\. Inclusion Criteria: 1. Patients aged 18-85 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).

Locations (1)

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China