TEAS Combined With Triple Antiemetic Drugs to Prevent PONV in High-Risk Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorZhejiang University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Patients with a history of allergy to the investigational drug or contraindications；
Long-QT syndrome ；
Pregnancy, lactation, or menstruation ；
Current smoker；
Trial design
Design model
Parallel
Treatments tested in this trial
transcutaneous electrical acupoint stimulation
DeviceUsing 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
DeviceThe 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
DrugDexamethasone 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.
Treatment groups
780 Participants
are divided into 2 treatment groupsGroup A: The TEAS groupExperimental treatment 2 interventions
Group B: The control groupSham comparator 2 interventions
Trial outcomes
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
Time frame
2 hours post-operation, 6 hours post-operation, 24 hours post-operationSecondary outcomes
1
Number of Participants Experiencing Postoperative Nausea in 48 h Postoperatively
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.
Time frame
2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation2
Number of Participants Experiencing Postoperative Vomiting in 48 h Postoperatively
including retching and vomiting
Time frame
2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation3
Need of Postoperative Metoclopramide
Need of Postoperative Metoclopramide
Time frame
2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operationSponsors and contacts
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Zhejiang University
Lead sponsor
Jinhua Central Hospital
Collaborator
Huzhou Central Hospital
Collaborator
The First People's Hospital of Huzhou
Collaborator
Source ClinicalTrials.gov