Transcutaneous Electrical Acupoint Stimulation Combined With Traditional Conscious Sedation for Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Sham-Controlled, Multicenter Trial With Mechanistic Substudy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Composite Incidence of Sedation-Related Adverse Events
研究概览
简要总结
- 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.
- 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:
- Active TEAS: Electrical stimulation at specific points on the legs and arms before and during ERCP.
- 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).
详细描述
- 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. 2. Study Design and Methodology:
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Inclusion Criteria:
- •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.
排除标准
- •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.
- •3. 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).
- •Life-threatening deterioration during endoscopy (e.g., uncontrolled bleeding, respiratory failure, cardiac arrest).
- •Voluntary withdrawal of consent by participant or legal representative at any time.
- •Occurrence of a major ERCP-related complication (e.g., perforation, major bleeding, severe pancreatitis) requiring surgical or intensive care intervention.
- •Principal investigator-identified safety risks (e.g., sepsis, acute liver failure).
研究组 & 干预措施
Active 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.
干预措施: TEAS + Conscious Sedation (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.
干预措施: Sham TEAS + Conscious Sedation (Other)
结局指标
主要结局
Composite Incidence of Sedation-Related Adverse Events
时间窗: From start of sedation until discharge from post-anesthesia care unit (approximately 1-3 hours)
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).
次要结局
- Endoscopist Satisfaction(Immediately after the endoscopy procedure)
- Procedure Success Rate(Immediately after the endoscopy procedure)
- Pain Score During Ampullary Cannulation(During ampullary cannulation)
- Pain Score at 30 Minutes Post-Procedure(30 minutes post-procedure)
- Sedation Depth During Ampullary Cannulation(During ampullary cannulation)
- Total Dose of Sedatives(Immediately after procedure)
- Patient Satisfaction(At post-anesthesia care unit discharge (approximately 1-2 hours post-procedure))
- Incidence of Postoperative Nausea and Vomiting (24 Hours)(Within 24 hours post-procedure)
- Incidence of Post-ERCP Pancreatitis(Within 24 hours post-procedure)
研究者
Liu Yan
Chief of Gastroenterology and Hepatology
Beijing 302 Hospital