An interventional study of TEAS + Conscious Sedation and Sham TEAS + Conscious Sedation in Endoscopic Retrograde Cholangiopancreatography, Conscious Sedation Adverse Event and Procedural Pain, sponsored by Beijing 302 Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Beijing 302 Hospital · Not applicable, Interventional, and Treatment
(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:
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).
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 (elevating β-endorphin), modulate autonomic nervous system activity, reduce perioperative opioid requirements, suppress excessive inflammatory responses (reducing TNF-α and IL-6), 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 with an embedded mechanistic substudy aims to rigorously evaluate whether adjunctive TEAS improves procedural safety, tolerance, and clinical outcomes in patients undergoing ERCP, while simultaneously exploring the underlying neuro-endocrine-immune mechanisms.
This is a prospective, randomized, sham-controlled, double-blind, parallel-group, multicenter trial with an embedded mechanistic substudy conducted at four centers: The Fifth Medical Center (lead site), The First Medical Center, The Third Medical Center of Chinese PLA General Hospital, and one additional participating site.
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 stratified block randomization (block sizes 4 and 6), with allocation concealment in sequentially numbered, opaque, sealed envelopes.
Participants will be allocated to one of two groups:
3.Sample Size Calculation: Based on the primary outcome measure (composite incidence of SRAEs), from pilot data (n=30; SRAE rates: TEAS 13.3%, sham 33.3%) and published literature, the estimated incidence of SRAEs under traditional sedation is 25%. We hypothesize that active TEAS can reduce this to 12.5% (a 50% relative risk reduction). Using a two-sided α = 0.05 and a power of 80%, a total of 118 patients (59 per group) is required (χ² test). To account for a 10% dropout rate, the target sample size is increased to 130 patients (65 per group). This sample size is also sufficient to detect moderate-to-large effect sizes (Cohen's d ≈ 0.5-0.6) for the mechanistic biomarker analyses.
4.Statistical Analysis Plan:
5.Scientific Justification: The selection of specific acupoints (PC6, SP10, SP9, GB34) is based on traditional Chinese medicine principles and modern physiological understanding: PC6 calms the spirit, suppresses nausea, and regulates cardiovascular function via modulation of autonomic tone; SP10 invigorates blood circulation, alleviates pain, and has anti-inflammatory properties; SP9 strengthens the spleen, resolves dampness, and provides adjunctive analgesia; GB34 relaxes tendons, activates collaterals, produces analgesia, and enhances dynamic cerebral autoregulation. The sham-controlled design is crucial for isolating the specific effects of electrical neuromodulation from non-specific placebo effects. The embedded mechanistic substudy, measuring β-endorphin, cortisol, TNF-α, and IL-6, will provide insights into the neuro-endocrine-immune pathways through which TEAS exerts its clinical 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.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 130 is above the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Beijing 302 Hospital is the lead sponsor of 88 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
1. Inclusion Criteria:
2. Exclusion Criteria:
3. Dropout Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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: 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.
Other: Sham 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.
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.
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).
Time frame: From start of sedation until discharge from post-anesthesia care unit (approximately 1-3 hours)
Procedure Success Rate
Defined as successful cannulation of the desired duct (bile or pancreatic duct) and completion of the intended diagnostic or therapeutic intervention.
Time frame: Immediately after the endoscopy procedure
Total Dose of Sedatives and Analgesics
Meperidine and diazepam total dosage (mg).
Time frame: Immediately after procedure
Mean Arterial Pressure (MAP)
Mean arterial pressure (MAP) measured in mmHg at the following time points: baseline, after sedation, at scope insertion, every 5 minutes during the procedure, at end of procedure, and at post-anesthesia care unit (PACU) discharge. Multiple measurements over time will be summarized as the mean of all intra-procedural measurements for each participant, and group-level comparisons will be performed using a linear mixed model.
Time frame: From baseline through PACU discharge (approximately 1-3 hours)
Heart Rate (HR)
Heart rate (HR) measured in beats per minute (bpm) at the following time points: baseline, after sedation, at scope insertion, every 5 minutes during the procedure, at end of procedure, and at post-anesthesia care unit (PACU) discharge. Multiple measurements over time will be summarized as the mean of all intra-procedural measurements for each participant, and group-level comparisons will be performed using a linear mixed model.
Time frame: From baseline through PACU discharge (approximately 1-3 hours)
Patient Tolerance
Assessed using a 10-point Visual Analogue Scale (VAS, 0 = no discomfort, 10 = worst imaginable discomfort) at 30 minutes post-procedure.
Time frame: 30 minutes post-procedure
Recovery Time
Time from end of procedure until patient is oriented (can state name, age, date of birth).
Time frame: Post-procedure (approximately 10-60 minutes)
Discharge Time
Time from end of procedure until a Modified Aldrete Score of ≥9 is achieved.
Time frame: Post-procedure (approximately 0.5-2 hours)
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).
Time frame: At post-anesthesia care unit discharge (approximately 1-2 hours post-procedure)
Endoscopist Satisfaction
Assessed by the performing gastroenterologist immediately after the procedure using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
Time frame: Immediately after the endoscopy 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.
Time frame: 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).
Time frame: Within 7 days post-procedure
Change in Serum β-endorphin Level
Change from baseline (before TEAS/sham initiation) to 2 hours post-ERCP completion. Measured by high-sensitivity ELISA kit.
Time frame: Baseline and 2 hours post-procedure
Change in Serum Cortisol Level
Change from baseline (before TEAS/sham initiation) to 2 hours post-ERCP completion. Measured by high-sensitivity ELISA kit.
Time frame: Baseline and 2 hours post-procedure
Change in Serum TNF-α Level
Change from baseline (before TEAS/sham initiation) to 2 hours post-ERCP completion. Measured by high-sensitivity ELISA kit.
Time frame: Baseline and 2 hours post-procedure
Change in Serum IL-6 Level
Change from baseline (before TEAS/sham initiation) to 2 hours post-ERCP completion. Measured by high-sensitivity ELISA kit.
Time frame: Baseline and 2 hours post-procedure
Blinding Assessment
Patients asked to guess their group assignment (active TEAS, sham TEAS, or uncertain) at PACU discharge.
Time frame: At post-anesthesia care unit (PACU) discharge, approximately 15 minutes after the end of the procedure
Plan to share: No — 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.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Aug 2027, 11 months later.
Of 141 non-industry interventional studies with no phase under Pain, Procedural, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 11 months is above that.
Counting every sponsor, half of 141 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Beijing 302 Hospital