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Active Not RecruitingNCT06241547

PONV Prevention Via Percutaneous Nerve Electrical Stimulation on PC6

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

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
302 (estimated)
Sponsor
Peking Union Medical College Hospital · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

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

Interventions

TypeNameDescription
DEVICEelectrical stimualtion via EmeTerm braceletWe planned to exert electrical stimulation via the bracelet.
DRUGantimetic drugs( dexamethasone,ondansetron)Antimetic drugs (dexamethasone ondansetron) are used to prevent postoperative nausea and vomiting.

Timeline

Start date
2024-01-12
Primary completion
2026-01-10
Completion
2026-03-30
First posted
2024-02-05
Last updated
2026-04-13

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06241547. Inclusion in this directory is not an endorsement.

PONV Prevention Via Percutaneous Nerve Electrical Stimulation on PC6 (NCT06241547) · Clinical Trials Directory