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

I-23PJ1712

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.

2024-01-12

2024-12-30

2024-12-30

Recruiting

Early phase I

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 302, 'type': 'ESTIMATED'}}

2024-05-09