PONV Prevention Via Percutaneous Nerve Electrical Stimulation on PC6

Last updated: December 6, 2024
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Vomiting

Colic

Stomach Discomfort

Treatment

electrical stimualtion via EmeTerm bracelet

antimetic drugs（ dexamethasone，ondansetron）

Clinical Study ID

NCT06241547
I-23PJ1712
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 arewilling to participate in this research by providing written informed consent.

Exclusion

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.

Study Design

Total Participants: 302
Treatment Group(s): 2
Primary Treatment: electrical stimualtion via EmeTerm bracelet
Phase: 2
Study Start date:
January 12, 2024
Estimated Completion Date:
December 30, 2024

Study 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.

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing,
    China

    Active - Recruiting

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