About this trial
The purpose of this clinical trial is to understand the effect of percutaneous acupoint electrical stimulation on postoperative gastrointestinal dysfunction. It will also investigate the safety of percutaneous acupoint electrical stimulation. The main questions that this trial aims to answer are:
Can percutaneous acupoint electrical stimulation alleviate postoperative gastrointestinal dysfunction? Through which mechanisms do they function?
Participants will:
Preoperatively, patients were either given or not given percutaneous acupoint electrical stimulation.
Record their symptoms and biological indicators within 5 days after the operation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years
BMI < 28 kg/m2
ASA classification is I-III grade
Laparoscopic urological procedures under general anesthesia, including but not limited to laparoscopic nephrectomy and laparoscopic radical prostatectomy for prostate cancer
Disqualifiers
Comprehensive assessment of severe cardiovascular, pulmonary and cerebrovascular diseases (such as severe coronary heart disease, valve diseases, respiratory failure, cerebral hemorrhage, cerebral infarction, etc.)
Preoperative use of analgesic and gastrointestinal motility drugs
TEAS contraindications (having electronic devices in the body, skin damage or infection at the stimulation site)
Previous history of TEAS or electro-acupuncture treatment
Trial design
Parallel
Treatments tested in this trial
Transcutaneous electrical acupoint stimulation
DeviceBefore the operation, the patient received transcutaneous electrical acupoint stimulation (TEAS) at bilateral Zusanli (ST 36), Neiguan (PC 6), and Ciliao (BL 32) acupoints with sterilized electrode patches. The stimulation intensity and current intensity that gave the patient an effective pricking sensation ("deqi") were maintained for 30 minutes. The stimulation method in the post-anesthesia care unit (PACU) was consistent with that before the operation.
Sham transcutaneous Electrical Acupoint Stimulation
DeviceBefore the operation, disinfection patches with electrodes were applied to Zusanli (ST 36), Neiguan (PC 6), and Ciliao (BL 32) acupointst, but no electrical stimulation was conducted. The stimulation method in the post-anesthesia care unit (PACU) was the same as that before the operation.
Treatment groups
Trial outcomes
Primary outcomes
I-FEED(Intake, Feeling nauseated, Emesis, physical Exam, and Duration of symptoms)Score
The I-FEED score consists of five aspects: eating, nausea, vomiting, physical examination, and duration of symptoms. The lowest score is 0 and the highest is 14. The higher the score, the worse the result. The normal I-FEED score is 0-2 points. Postoperative gastrointestinal intolerance (POGI) is 3-5 points, and Postoperative gastrointestinal dysfunction (POGD) is ≥ 6 points.
Secondary outcomes
The time of the first postoperative defecation and flatus expulsion
The concentrations of motilin (MTL)
Platelet/lymphocyte ratio (PLR)
Visual analogue scale (VAS) Score
The VAS score refers to drawing a 10-cm scale on a piece of paper. One end of the scale is marked as 0, indicating no pain; the other end is marked as 10, indicating severe pain; the values in between represent different degrees of pain.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.