PONV Prevention Via Percutaneous Nerve Electrical Stimulation on PC6

Phase 2

Recruiting

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Device: electrical stimualtion via EmeTerm bracelet; Drug: antimetic drugs（ dexamethasone，ondansetron）

• Registration Number: NCT06241547
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2023-10-31
• Study Start: 2024-01-12
• Study First Submitted QC: 2024-01-27
• Study First Posted: 2024-02-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 302

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 are willing to participate in this research by providing written informed consent.

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stimulation group	electrical stimualtion via EmeTerm bracelet	accept general drug prevention, wear the equipment, and receive electrical stimulation.
stimulation group	antimetic drugs（ dexamethasone，ondansetron）	accept general drug prevention, wear the equipment, and receive electrical stimulation.
control group	antimetic drugs（ dexamethasone，ondansetron）	accept general drug prevention and wear the equipment but receive no electrical stimulation

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative nausea and vomiting(PONV)	24 hours after surgery	Ask patients if they experienced nausea or vomiting 24 hours after surgery.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China