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

NCT07440342 | Not Yet Recruiting DMC

• 1 other identifier: 2026-TEAS-ERCP
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.The main questions the study aims to answer are:
3. 3.Active TEAS: Electrical stimulation at specific points on the legs and arms before and during ERCP.
4. 4.Sham TEAS: Pads placed on the same points but no electrical stimulation delivered (the device appears active).

Conditions

Endoscopic Retrograde Cholangiopancreatography; Procedural Pain; Sedation-related Complications; Conscious Sedation Adverse Event

Keywords

Transcutaneous Electrical Acupoint Stimulation; ERCP; Conscious Sedation; Diazepam; Sedation-Related Adverse Events; Acupuncture; Non-Pharmacological Intervention; Neuro-endocrine-immune Mechanisms; Inflammatory Cytokines; Cortisol; β-endorphin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Procedure Success Rate

  Immediately after the endoscopy procedure

• Total Dose of Sedatives and Analgesics

  Immediately after procedure

• Mean Arterial Pressure (MAP)

  From baseline through PACU discharge (approximately 1-3 hours)

• Heart Rate (HR)

  From baseline through PACU discharge (approximately 1-3 hours)

• Patient Tolerance

  30 minutes post-procedure

Other Outcomes (5)

• Change in Serum β-endorphin Level

  Baseline and 2 hours post-procedure

• Change in Serum Cortisol Level

  Baseline and 2 hours post-procedure

• Change in Serum TNF-α Level

  Baseline and 2 hours post-procedure

Study Arms (2)

Active TEAS + Conscious Sedation

EXPERIMENTAL

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, 2/20 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: TEAS + Conscious Sedation

Sham TEAS + Conscious Sedation

SHAM COMPARATOR

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.

Other: Sham TEAS + Conscious Sedation

Interventions

TEAS + Conscious Sedation OTHER

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, 2/20 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.

Active TEAS + Conscious Sedation

Sham TEAS + Conscious Sedation OTHER

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.

Sham TEAS + Conscious Sedation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-85 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 may not qualify if:

• 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.
• \. Dropout Criteria:
• Requirement for conversion to general anesthesia due to failed sedation or clinical necessity.
• Occurrence of a serious adverse event related to the study intervention (e.g., severe allergic reaction, hemodynamic collapse).

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

MeSH Terms

Conditions

Pain, Procedural

Interventions

Conscious Sedation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Liang Zheng, Doctor

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng Lu, Doctor

CONTACT

+86 10 18800153001; wuliangdoc@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Triple (Participant, Care Provider, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Gastroenterology and Hepatology

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)