Electrical acupoint stimulation plus three anti-nausea drugs to prevent post-op nausea in high-risk women
Transcutaneous Electrical Acupoint Stimulation Combined With Triple Antiemetic Drugs for Postoperative Nausea and Vomiting in High-Risk Patients: A Multicenter Randomized Controlled Trial
This trial will test whether adding wearable electrical acupoint stimulation to three anti-nausea drugs reduces postoperative nausea and vomiting in high-risk adult women having elective laparoscopic surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 780 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07480785 on ClinicalTrials.gov |
What this trial studies
This randomized, blinded interventional study will enroll 780 women aged 18–65 with high PONV risk (Apfel score ≥3) undergoing elective laparoscopic procedures. All participants receive a standardized triple antiemetic regimen (dexamethasone, palonosetron, droperidol) and are randomized to active transcutaneous electrical acupoint stimulation (TEAS at P6 and L14) or a sham stimulation control. Active TEAS is applied from 30 minutes before induction and maintained through recovery, while sham stimulation uses minimal perceptible current for 1 minute. Outcomes include incidence of postoperative nausea and vomiting and need for rescue antiemetics, with blinded data collection by trained anesthesiologists.
Who should consider this trial
Good fit: Adult women (18–65 years) at high risk for PONV (Apfel score ≥3) scheduled for elective laparoscopic surgery who meet ASA I–III criteria are ideal candidates.
Not a fit: Patients who are current smokers, pregnant or breastfeeding, have implanted cardiac devices, severe hepatic/renal impairment, or other listed exclusions are unlikely to be eligible or to receive benefit from this approach.
Why it matters
Potential benefit: If successful, the addition of TEAS could meaningfully reduce post-surgery nausea and vomiting and lower the need for rescue medications.
How similar studies have performed: Prior smaller studies of P6 acupoint stimulation have shown reductions in PONV when combined with antiemetics, but results have been mixed and adequately powered randomized data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women scheduled for laparoscopic surgery ； * Aged 18-65 years； * ASA Class I-III； * Apfel score ≥ 3 (female sex, non-smoker, history of PONV and/or motion sickness). Exclusion Criteria: * Patients with a history of allergy to the investigational drug or contraindications； * Long-QT syndrome ； * Pregnancy, lactation, or menstruation ； * Current smoker； * Nausea/vomiting or use of antiemetics, opioids, or systemic corticosteroids within 24 h before surgery； * Requirement for post-operative sedation and mechanical ventilation ； * Severe renal or hepatic impairment ； * Psychiatric or neurological disorder ； * Vertebrobasilar insufficiency； * Vestibular disease； * Language or communication barrier ； * Skin lesion or infection at the acupoint stimulation site ； * Upper-limb nerve injury ； * Implanted cardiac pacemaker or defibrillator ； * Participation in another clinical trial within the past 4 weeks.
Where this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Diansan Su, PhD
- Email: diansansu@yahoo.com
- Phone: +8618616514088
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.