PONV Prevention Via Percutaneous Nerve Electrical Stimulation on PC6

January 27, 2024 updated by: Peking Union Medical College Hospital

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

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

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: stimulation group
accept general drug prevention, wear the equipment, and receive electrical stimulation.
Device: electrical stimualtion via EmeTerm bracelet
We planned to exert electrical stimulation via the bracelet.
Drug: antimetic drugs（ dexamethasone，ondansetron）
Antimetic drugs (dexamethasone ondansetron) are used to prevent postoperative nausea and vomiting.
Placebo Comparator: control group
accept general drug prevention and wear the equipment but receive no electrical stimulation
Drug: antimetic drugs（ dexamethasone，ondansetron）
Antimetic drugs (dexamethasone ondansetron) are used to prevent postoperative nausea and vomiting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2024

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

January 27, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

February 5, 2024

Last Update Submitted That Met QC Criteria

January 27, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-23PJ1712

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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