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NCT Number: NCT07480785

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous electrical acupoint stimulation

Device

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.

Sham Transcutaneous Electrical Acupoint Stimulation

Device

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.

triple antiemetic drugs

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Diansan Su, PhD

CONTACT

[email protected]

+8618616514088

Dongdong Tian

CONTACT

[email protected]

+8615924165551

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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