Shock therapy? no, just a gentle tingle to ease ERCP sedation risks
NCT ID NCT07440342
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a gentle electrical current applied to specific points on the skin (called TEAS) can reduce side effects like low oxygen or blood pressure during a procedure to treat bile duct problems (ERCP). About 130 adults will be randomly assigned to receive either real TEAS or a fake version, while all get standard sedation. The goal is to see if TEAS makes the procedure safer and more comfortable, and to understand how it works in the body.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100039, China
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