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
Overview
- Phase
- Phase 2
- Intervention
- electrical stimualtion via EmeTerm bracelet
- Conditions
- Postoperative Nausea and Vomiting
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 302
- Locations
- 1
- Primary Endpoint
- Incidence of postoperative nausea and vomiting(PONV)
- Status
- Active, Not Recruiting
- Last Updated
- 19 days ago
Overview
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.
Investigators
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.
Arms & Interventions
stimulation group
accept general drug prevention, wear the equipment, and receive electrical stimulation.
Intervention: electrical stimualtion via EmeTerm bracelet
stimulation group
accept general drug prevention, wear the equipment, and receive electrical stimulation.
Intervention: antimetic drugs（ dexamethasone，ondansetron）
control group
accept general drug prevention and wear the equipment but receive no electrical stimulation
Intervention: antimetic drugs（ dexamethasone，ondansetron）
Outcomes
Primary Outcomes
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.