Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 test whether TEAS improves procedural success and patient satisfaction. 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? 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, and satisfaction scores.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients aged 18-80 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.

Locations
Other Locations
China
The Fifth Medical Center of PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Zheng Lu, Doctor
wuliangdoc@163.com
+86 10 18800153001
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 130
Treatments
Experimental: Active TEAS + Conscious Sedation
Participants receive real Transcutaneous Electrical Acupoint Stimulation (TEAS) delivered via surface electrodes bilaterally at four predefined acupoints: Yinlingquan (SP9), Yanglingquan (GB34), Xuehai (SP10), and Neiguan (PC6). Stimulation (dense-disperse wave, 2/20 Hz alternating frequency, intensity 2-5 mA adjusted to patient tolerance) begins 30 minutes before ERCP and continues throughout the procedure and for 15 minutes after procedure completion. All participants receive standardized conscious sedation with intravenous meperidine (0.5 mg/kg) and diazepam (0.1 mg/kg) administered by a blinded anesthesiologist.
Sham_comparator: Sham TEAS + Conscious Sedation
Participants receive sham TEAS. Electrodes are placed identically to the Active TEAS Group at the same four acupoints (SP9, GB34, SP10, PC6) 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 identical standardized conscious sedation with intravenous meperidine (0.5 mg/kg) and diazepam (0.1 mg/kg) administered by a blinded anesthesiologist.
Related Therapeutic Areas
Sponsors
Leads: Beijing 302 Hospital

This content was sourced from clinicaltrials.gov