PONV Prevention Via Percutaneous Nerve Electrical Stimulation on PC6
NCT ID: NCT06241547
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
302 participants
INTERVENTIONAL
2024-01-12
2024-12-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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stimulation group
accept general drug prevention, wear the equipment, and receive electrical stimulation.
electrical stimualtion via EmeTerm bracelet
We planned to exert electrical stimulation via the bracelet.
antimetic drugs（ dexamethasone，ondansetron）
Antimetic drugs (dexamethasone ondansetron) are used to prevent postoperative nausea and vomiting.
control group
accept general drug prevention and wear the equipment but receive no electrical stimulation
antimetic drugs（ dexamethasone，ondansetron）
Antimetic drugs (dexamethasone ondansetron) are used to prevent postoperative nausea and vomiting.
Interventions
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electrical stimualtion via EmeTerm bracelet
We planned to exert electrical stimulation via the bracelet.
antimetic drugs（ dexamethasone，ondansetron）
Antimetic drugs (dexamethasone ondansetron) are used to prevent postoperative nausea and vomiting.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
Yes
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Chen Junjie
Role: primary
References
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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.
Other Identifiers
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I-23PJ1712
Identifier Type: -
Identifier Source: org_study_id