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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stimulation group | Experimental | accept general drug prevention, wear the equipment, and receive electrical stimulation. |
|
| control group | Placebo Comparator | accept general drug prevention and wear the equipment but receive no electrical stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electrical stimualtion via EmeTerm bracelet | Device | We planned to exert electrical stimulation via the bracelet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative nausea and vomiting(PONV) | Ask patients if they experienced nausea or vomiting 24 hours after surgery. | 24 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39313286 | Derived | 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. |
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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.
5 years after study completion
e-mail to tracymaobao@126.com
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| antimetic drugs( dexamethasone,ondansetron) | Drug | Antimetic drugs (dexamethasone ondansetron) are used to prevent postoperative nausea and vomiting. |
|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |