Preventing nausea and vomiting after surgery using electrical stimulation
Perioperative Percutaneous Electrical Nerve Stimulation Via a Wearable Equipment on Postoperative Nausea and Vomiting（PONV） in Patients Undergoing Laparoscopy Abdominal Surgery: a Prospective Randomized Controlled Trial
This study is testing if a wearable device that uses electrical stimulation can help prevent nausea and vomiting after surgery for people having laparoscopic procedures.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 302 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06241547 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of percutaneous electrical nerve stimulation at the Pericardium 6 (PC6) point using a wearable device to prevent postoperative nausea and vomiting in patients undergoing elective laparoscopic surgery. Approximately 302 participants will be randomly assigned to receive either active electrical stimulation or a placebo wristband. The stimulation will occur 30 minutes before surgery and continue for 24 hours postoperatively. The primary outcome is the incidence of postoperative nausea and vomiting, with secondary outcomes including recovery metrics and complications.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18-65 undergoing elective laparoscopic surgery with an ASA Grade of 1 to 3.
Not a fit: Patients with upper extremity nerve injuries, severe central nervous system diseases, or those requiring ICU care post-surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative nausea and vomiting, improving patient comfort and recovery.
How similar studies have performed: Other studies have shown promise in using electrical stimulation for nausea prevention, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18-65 years; 2. Patients undergoing elective laparoscopic surgery; 3. American Society of Anaesthesiologists(ASA) Grade 1 to 3; 4. Anesthesia: General Anesthesia, Tracheal Intubation; 5. BMI: ≥18, \<28; 6. Gender: female 7. Patients or their family members are able to comprehend the study protocol and are willing to participate in this research by providing written informed consent. Exclusion Criteria: 1. There are incisions or scars in the wearing position of the device; 2. There is a local infection in the wearing position of the device; 3. upper extremity nerve injury; 4. history of spinal cord surgery; 5. Participated in other clinical trials within 4 weeks; 6. suffering from severe central nervous system disease or mental disorder; 7. Patients need to return to the ICU after surgery.
Where this trial is running
Beijing
- Peking Union Medical College Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Chen Junjie
- Email: 1045034956@qq.com
- Phone: +8617330860407
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.