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Completed

NCT Number: NCT06241547

PONV Prevention Via Percutaneous Nerve Electrical Stimulation on PC6

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking Union Medical College Hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

electrical stimualtion via EmeTerm bracelet

Device

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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