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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Устройство 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.
• Препарат 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.

Первичные конечные точки

• Number of Participants Experiencing Nausea,Retching and Vomiting within 24 hours after operation. [Срок оценки: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation]

Вторичные конечные точки (3)

• Number of Participants Experiencing Postoperative Nausea in 48 h Postoperatively [Срок оценки: 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 [Срок оценки: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation]
• Need of Postoperative Metoclopramide [Срок оценки: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

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

Идентификаторы

NCT: NCT07480785 · ZJU_2025B1460

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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