Randomized, Controlled, Single-blind Exploratory Study of the Efficacy and Safety of Wrist and An… (NCT05873270) | Clinical Trial Compass
UnknownNot Applicable
Randomized, Controlled, Single-blind Exploratory Study of the Efficacy and Safety of Wrist and Ankle Acupuncture Intervention on Nausea, Vomiting and Pain After Sleeve Gastric Surgery in Women
China66 participantsStarted 2023-03-23
Plain-language summary
PONV is the most common clinical presentation after surgical procedures beyond pain. A retrospective study of our center found that the postoperative incidence of LSG was 77.4%. PONV can not only cause postoperative discomfort, but also cause serious complications such as disturbance water and electrolyte balance, wound splitting, incisional hernia, and even residual gastric leakage and aspiration pneumonia, resulting in prolonged hospital stay and increased medical costs. Wrist and ankle acupuncture is a special kind of acupuncture therapy. Through subcutaneous stimulation, the electrical signal is fed back along the nerve fiber into the cerebral cortex, without dialectical treatment, and only needs the appropriate symptoms and signs of the patient. Although only in the wrist and ankle, it can solve a series of problems in the whole body, especially nausea, vomiting and pain symptoms.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* In accordance with the Guidelines for Surgical Treatment of Obesity and Type 2 Diabetes in China (2019 edition);
* ASA grades II-III; Age: 18-65 years old;
* Denial of smoking history;
* Denied any history of motion sickness or PONV;
* Female patients proposed to undergo laparoscopic sleeve gastrectomy under elective general anesthesia;
* Voluntary attended and signed informed consent.
Exclusion Criteria:
* With known drug allergies related to this study;
* Severe heart, respiratory, renal or liver diseases, and coagulation disorders;
* Psychiatric or neurological disorders;
* difficulties in communication;
* Premedication or premedical conditions limits target assessment, including use of antiemetics, opioids or corticosteroids (excluding anesthetic medication);
* Gastroesophageal reflux (GRED), clinically assessed as severe GRED or preoperative gastroscopy indicating grade B of oesophagitis or above;
* Patients undergoing combined cholecystectomy and gynecological surgery during the operation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline pain at 24 hours after surgery
Timeframe: Change from Baseline pain at 24 hours after surgery
2
Change from Baseline nausea and vomitting at 24 hours after surgery
Timeframe: Change from Baseline nausea and vomitting at 24 hours after surgery