PONV Prevention Via Percutaneous Nerve Electrical Stimulation on PC6

NCT06241547 | Active Not Recruiting Phase 2

• 1 other identifier: I-23PJ1712
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative nausea and vomiting(PONV)

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

  24 hours after surgery

Study Arms (2)

stimulation group

EXPERIMENTAL

accept general drug prevention, wear the equipment, and receive electrical stimulation.

Device: electrical stimualtion via EmeTerm bracelet; Drug: antimetic drugs（ dexamethasone，ondansetron）

control group

PLACEBO COMPARATOR

accept general drug prevention and wear the equipment but receive no electrical stimulation

Drug: antimetic drugs（ dexamethasone，ondansetron）

Interventions

antimetic drugs（ dexamethasone，ondansetron） DRUG

Antimetic drugs (dexamethasone ondansetron) are used to prevent postoperative nausea and vomiting.

control group; stimulation group

electrical stimualtion via EmeTerm bracelet DEVICE

We planned to exert electrical stimulation via the bracelet.

stimulation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

Related Publications (1)

• Chen J, Che L, Cui Q, Lang J, Zhang Y, Zhu B, Huang Y. Acustimulation combined with pharmacological prophylaxis versus pharmacological prophylaxis alone in postoperative nausea and vomiting (PONV) prophylaxis among patients undergoing laparoscopy abdominal surgery: a research protocol for a randomised controlled trial. BMJ Open. 2024 Sep 23;14(9):e088633. doi: 10.1136/bmjopen-2024-088633.

  PMID: 39313286 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: February 5, 2024
• Study Start: January 12, 2024
• Primary Completion: January 10, 2026
• Study Completion: March 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 5 years after study completion
• Access Criteria: e-mail to tracymaobao@126.com

Locations

CN (1)