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

Official title

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

Overview

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.

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.

Interventions

• 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 stimulatio
• 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.
• 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.

Primary outcome measures

• 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]

Secondary outcome measures (3)

• 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]
• 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]
• Need of Postoperative Metoclopramide [Time frame: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

China · 1 center

• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT07480785 · ZJU_2025B1460

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗