PONV Prevention Via Percutaneous Nerve Electrical Stimulation on PC6

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Description

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.

Study Overview

Start Date
January 12, 2024
Completion Date
July 30, 2024
Enrollment
270
Date Posted
February 5, 2024
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
Peking Union Medical College Hospital
Beijing, China

Eligibility

Minimum Age (years)
18
Maximum Age (years)
65
Eligibility Criteria
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.

Study Contact Info

Study Contact Name
Chen Junjie
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
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 245 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.
NCTid (if applicable)
NCT06241547