Actively Recruiting
Transcutaneous Electrical Acupoint Stimulation Combined With Triple Antiemetic Drugs for Postoperative Nausea and Vomiting in High-Risk Patients: A Multicenter Randomized Controlled Trial
Led by Zhejiang University · Updated on 2026-03-18
780
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
J
Jinhua Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of transcutaneous electrical acupoint stimulation (TEAS) combined with triple antiemetic drugs to prevent postoperative nausea and vomiting (PONV) in female patients at high risk undergoing elective laparoscopic surgery. This trial aims to determine if adding TEAS to a standard triple-drug antiemetic regimen reduces the incidence of PONV more than the drugs alone. The study involves 780 women aged 18 to 65 years with specific risk factors for PONV. Participants will be randomly assigned to either the TEAS group or a control group receiving sham stimulation. In the TEAS group, electrical stimulation is applied to specific acupoints on the upper limbs starting 30 minutes before anesthesia induction and continued until discharge from the operating room. Both groups receive the same triple antiemetic drug regimen including dexamethasone, palonosetron, and droperidol, with rescue metoclopramide if needed. The control group receives minimal current stimulation for one minute to maintain blinding. During the study, trained anesthesiologists blinded to group assignments will collect data on nausea, retching, and vomiting episodes at 2, 6, and 24 hours post-operation, with additional follow-up up to 48 hours. The primary outcome is the number of participants experiencing these symptoms within 24 hours. Safety and treatment effects will be monitored throughout the hospital stay, with assessments continuing until discharge from the post-anesthesia care unit.
CONDITIONS
Brief Title
TEAS Combined With Triple Antiemetic Drugs to Prevent PONV in High-Risk Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women scheduled for laparoscopic surgery
- Aged 18 to 65 years
- ASA Class I to III
- Apfel score of 3 or higher (female sex, non-smoker, history of PONV and/or motion sickness)
You will not qualify if you...
- Allergy history or contraindications to investigational drugs
- Long-QT syndrome
- Pregnancy, lactation, or menstruation
- Current smoker
- Nausea, vomiting, or use of antiemetics, opioids, or corticosteroids within 24 hours before surgery
- Requirement for postoperative sedation and mechanical ventilation
- Severe kidney or liver impairment
- Psychiatric or neurological disorder
- Vertebrobasilar insufficiency
- Vestibular disease
- Language or communication barriers
- Skin lesions or infection at acupoint stimulation sites
- Upper-limb nerve injury
- Implanted cardiac pacemaker or defibrillator
- Participation in another clinical trial within the past 4 weeks
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive transcutaneous electrical acupoint stimulation starting approximately 30 minutes before anesthesia induction until discharge from the post-anesthesia care unit, combined with triple antiemetic drugs administered during surgery.
1 baseline visit (day of surgery)
Duration - 48 hours post-operation
Participants are monitored for nausea, vomiting, and the need for rescue medication up to 48 hours after surgery.
Assessments at 2, 6, 24, and 48 hours post-operation
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
D
Diansan Su, PhD
D
Dongdong Tian
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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