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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06241547
- Acronym / sponsor ID
- I-23PJ1712
- Conditions
- Postoperative Nausea and Vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 13 May 2026 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stimulation group | Experimental | Device: electrical stimualtion via EmeTerm bracelet, Drug: antimetic drugs（ dexamethasone，ondansetron）accept general drug prevention, wear the equipment, and receive electrical stimulation. |
| control group | Placebo comparator | Drug: antimetic drugs（ dexamethasone，ondansetron）accept general drug prevention and wear the equipment but receive no electrical stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical stimualtion via EmeTerm braceletWe planned to exert electrical stimulation via the bracelet. | Device | stimulation group |
| antimetic drugs（ dexamethasone，ondansetron）Antimetic drugs (dexamethasone ondansetron) are used to prevent postoperative nausea and vomiting. | Drug | control group, stimulation group |
Primary outcome
Incidence of postoperative nausea and vomiting(PONV)
Time frame: 24 hours after surgery
Ask patients if they experienced nausea or vomiting 24 hours after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Derived from this study: PubMed 39313286Chen 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative nausea and vomiting(PONV) (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06241547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.