TEAS Combined With Triple Antiemetic Drugs to Prevent PONV in High-Risk Patients

March 15, 2026 updated by: Diansan Su, Zhejiang University

Transcutaneous Electrical Acupoint Stimulation Combined With Triple Antiemetic Drugs for Postoperative Nausea and Vomiting in High-Risk Patients: A Multicenter Randomized Controlled Trial

The goal of this clinical trial is to evaluate the effects of transcutaneous electrical acupoint stimulation (TEAS) combined with triple antiemetics for postoperative nausea and vomiting (PONV) in high-risk patients.

The primary question it seeks to answer is:

Does TEAS combined with triple antiemetics further reduce the incidence of PONV in high-risk subjects? Researchers will compare active TEAS with sham stimulation to determine whether the addition of TEAS to dexamethasone, palonosetron, and droperidol lowers the PONV rate beyond that achieved by the triple-drug prophylaxis alone.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

780 female patients, aged between 18 to 65 y, who are scheduled for elective laparoscopic surgery requiring general anesthesia, will be randomly allocated to acustimulation group (Group TEAS), or the control group.

In Group TEAS, a surface electrode will be applied to the P6 and L14 acupoint 30 min before induction. An operator will set electric stimulating current at 1mA with frequency at 2 Hz, and gradually increased the current intensity to a little below discomfort threshold. The stimulation will be maintained until the patient is discharged from the operation. In the control group the same protocol was applied for percutaneous acupoint electrical stimulation, initiated before anesthesia induction with the minimum perceptible current (MPC) and terminated after 1 minute.

A standardized anesthetic protocol will be followed. In all groups, dexamethasone 5mg and palonosetron 0.25mg i.v. will be given after induction, and droperidol 1.25 mg i.v. will be given during the abdominal closure. After surgery, metoclopramide 10mg i.v. will be administered as a rescue therapy to any patient who experiences an episode of moderate or severe nausea, an episode of vomiting, and requests rescue medication.

The patients shall be unaware of the group assignments. An anesthesiologist, who are trained for the study and blinded to the randomization, will collect the data.

Study Type

Interventional

Enrollment (Estimated)

780

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The TEAS group
The TEAS group，Nei-guan (PC6) and He-gu (LI4) were stimulated by a transcutaneous acupoint electrical stimulation instrument approximately 30 minutes before anesthesia induction until the patient is discharged from the operating room.
Device: transcutaneous electrical acupoint stimulation
Using the Huatuo brand electronic acupuncture therapy device (Model: SDZ-Ⅲ, produced by Suzhou Medical Equipment Co., Ltd., China), bilateral upper limb acupoints P6+L14 were selected. Approximately 30 minutes before anesthesia induction, the electrodes were connected with the initial current set at 1 milliampere and frequency at 2/100 Hz. The current intensity was gradually increased until the patient felt pain or reached the discomfort threshold (ranging between 6 to 10 mA), and the stimulation was maintained until the patient was discharged from the PACU.
Drug: triple antiemetic drugs
Dexamethasone 5mg and palonosetron 0.25mg i.v. will be given after induction, and droperidol 1.25 mg i.v. will be given during the abdominal closure.
Sham Comparator: The control group
The same protocol was applied for percutaneous acupoint electrical stimulation, initiated before anesthesia induction with the minimum perceptible current (MPC) and terminated after 1 minute. To ensure complete blinding, both groups were covered with opaque sheets over the percutaneous acupoint electrical stimulation device.
Drug: triple antiemetic drugs
Dexamethasone 5mg and palonosetron 0.25mg i.v. will be given after induction, and droperidol 1.25 mg i.v. will be given during the abdominal closure.
Device: Sham transcutaneous electrical acupoint stimulation
The same protocol was applied for percutaneous acupoint electrical stimulation, initiated before anesthesia induction with the minimum perceptible current (MPC) and terminated after 1 minute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Nausea,Retching and Vomiting within 24 hours after operation.
Time Frame: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation
The number of episodes of nausea, retching and vomiting within 24 hours after operation
2 hours post-operation, 6 hours post-operation, 24 hours post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Postoperative Nausea in 48 h Postoperatively
Time Frame: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation
Nausea score: The severity of PON was measured using a visual analog scale (VAS), with 0 indicating no symptoms and 10 representing the most severe imaginable symptoms.
2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation
Number of Participants Experiencing Postoperative Vomiting in 48 h Postoperatively
Time Frame: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation
including retching and vomiting
2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation
Need of Postoperative Metoclopramide
Time Frame: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation
Need of Postoperative Metoclopramide
2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Collaborators

The First People's Hospital of Huzhou
Jinhua Central Hospital
Huzhou Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJU_2025B1460

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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