The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
NCT Number: NCT07480785
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.
Interested in participating?
Request Info18 year–65 year
Female
Interventional
Not applicable
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 same protocol was applied for percutaneous acupoint electrical stimulation, initiated before anesthesia induction with the minimum perceptible current (MPC) and terminated after 1 minute.
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.
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
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.
Time frame: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation
including retching and vomiting
Time frame: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation
Need of Postoperative Metoclopramide
Contact information is provided by the study sponsor or research team.
Diansan Su, PhD
CONTACT
Dongdong Tian
CONTACT
Zhejiang University
Other
Transcutaneous Electrical Acupoint Stimulation Combined With Triple Antiemetic Drugs for Postoperative Nausea and Vomiting in High-Risk Patients: A Multicenter Randomized Controlled Trial
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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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