PONV Prevention Via Percutaneous Nerve Electrical Stimulation on PC6

Peking Union Medical College Hospital326 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

326

Conditions

Postoperative Nausea and Vomiting

Interventions

electrical stimualtion via EmeTerm braceletDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Peking Union Medical College Hospital

Beijing, China

Outcomes

Primary Outcomes

Incidence of postoperative nausea and vomiting(PONV)

Ask patients if they experienced nausea or vomiting 24 hours after surgery.

Time frame: 24 hours after surgery

Data from ClinicalTrials.gov

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