Postoperative Nausea and VomitingPhase 2NCT06241547
PONV Prevention Via Percutaneous Nerve Electrical Stimulation on PC6
A Phase 2 study testing electrical stimualtion via EmeTerm bracelet and antimetic drugs（ dexamethasone，ondansetron） in people with Postoperative Nausea and Vomiting, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study aims to certify the effectiveness of percutaneous electrical nerve stimulation at Pericardium 6 (PC6) via a wearable equipment during perioperative period on preventing postoperative nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- electrical stimualtion via EmeTerm bracelet and antimetic drugs（ dexamethasone，ondansetron）
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2024to 13 May 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years;
- Patients undergoing elective laparoscopic surgery;
- American Society of Anaesthesiologists(ASA) Grade 1 to 3;
- Anesthesia: General Anesthesia, Tracheal Intubation;
- BMI: ≥18, <28;
- Gender: female
- 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.
Who cannot join
- There are incisions or scars in the wearing position of the device;
- There is a local infection in the wearing position of the device;
- upper extremity nerve injury;
- history of spinal cord surgery;
- Participated in other clinical trials within 4 weeks;
- suffering from severe central nervous system disease or mental disorder;
- Patients need to return to the ICU after surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 aims to certify the effectiveness of percutaneous electrical nerve stimulation at Pericardium 6 (PC6) via a wearable equipment during perioperative period on preventing postoperative nausea and vomiting.
Read the detailed description
Introduction: This study aims to certify the effectiveness of percutaneous electrical nerve stimulation at Pericardium 6 (PC6) via a wearable equipment during perioperative period on preventing postoperative nausea and vomiting.
Method and analysis: A total of approximately 302 patients undergoing elective laparoscopic surgery will be enrolled. Participants will be randomly assigned to either a electrical stimulation group or a placebo group, with computer-generated randomization and concealed allocation using sealed envelopes. The electrical stimulation group will receive PC point electrical stimulation 30 minutes before surgery until 24 hours postoperatively, while the placebo group will wear a wristband without stimulation. The primary outcome will be the incidence of postoperative nausea and vomiting, with secondary outcomes including the incidence of nausea and vomiting within 24 hours after surgery, gastrointestinal and hemodynamic indices, postoperative recovery, hospital stay and cost, and complications.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- electrical stimualtion via EmeTerm bracelet, antimetic drugs（ dexamethasone，ondansetron）
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical stimualtion via EmeTerm braceletDevice
We planned to exert electrical stimulation via the bracelet.
antimetic drugs（ dexamethasone，ondansetron）Drug
Antimetic drugs (dexamethasone ondansetron) are used to prevent postoperative nausea and vomiting.
| Study group | Role | What they receive |
|---|---|---|
| stimulation group | Experimental | accept general drug prevention, wear the equipment, and receive electrical stimulation. Receives: Device: electrical stimualtion via EmeTerm bracelet; Drug: antimetic drugs（ dexamethasone，ondansetron） |
| control group | Placebo comparator | accept general drug prevention and wear the equipment but receive no electrical stimulation Receives: Drug: antimetic drugs（ dexamethasone，ondansetron） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and vomiting(PONV)
Ask patients if they experienced nausea or vomiting 24 hours after surgery.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start5 Feb 2024
- Primary completion10 Jan 2026
- Study completion13 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241547
- Sponsor's protocol ID
- I-23PJ1712
- Status last verified
- Jun 2026
- First submitted
- 31 Oct 2023
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Response: Thank you for your comment. We plan to share Individual Participant Data (IPD) upon request. Researchers interested in accessing the data can contact the corresponding author via email. The data will be shared following a review of the request to ensure that it complies with ethical guidelines and protects participant privacy.
Publications
Chen J, Che L, Cui Q, Lang J, Zhang Y, Zhu B, Huang Y. Acustimulation combined with pharmacological prophylaxis versus pharmacological prophylaxis alone in postoperative nausea and vomiting (PONV) prophylaxis among patients undergoing laparoscopy abdominal surgery: a research protocol for a randomised controlled trial. BMJ Open. 2024 Sep 23;14(9):e088633. doi: 10.1136/bmjopen-2024-088633.
PubMed 39313286