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

NCT07480785 | Recruiting

• 1 other identifier: ZJU_2025B1460
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uterine Fibroids (Leiomyoma); Ovarian Tumors; Gallstones

Keywords

postoperative nausea and vomiting; transcutaneous electrical acupoint stimulation; high-risk patients with PONV

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Nausea,Retching and Vomiting within 24 hours after 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 Outcomes (3)

• Number of Participants Experiencing Postoperative Nausea in 48 h Postoperatively

  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

  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

Study Arms (2)

The TEAS group

EXPERIMENTAL

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; Drug: triple antiemetic drugs

The control group

SHAM COMPARATOR

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.

Device: Sham transcutaneous electrical acupoint stimulation; Drug: triple antiemetic drugs

Interventions

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.

The TEAS group

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.

The control group

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.

The TEAS group; The control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead
• Jinhua Central Hospital: collaborator
• Huzhou Central Hospital: collaborator
• The First People's Hospital of Huzhou: collaborator

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Leiomyoma; Ovarian Neoplasms; Gallstones; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Central Study Contacts

Diansan Su, PhD

CONTACT

+8618616514088; diansansu@yahoo.com

Dongdong Tian

CONTACT

+8615924165551; tddcomeon@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both acupoint stimulation and placebo treatment will be administered by the same investigator, who will take no part in anesthesia management or data collection. To maintain blinding, an opaque drape will be placed over the TEAS unit in both groups. All participants will be informed that they may or may not feel a tingling sensation at the wrists while the device is operating. Follow-up and data collection will be performed by a separate investigator who is uninvolved in routine anesthesia care and blinded to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of the Department of Anesthesiology

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 18, 2026
• Study Start: January 16, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-02

Locations

CN (1)