Clinical trial NCT04043247: Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting
Official title: Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting: a Multicenter, Evaluator-Blind, Randomized and Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: Postoperative Nausea and Vomiting;TEAS
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 1655
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative nausea and vomiting(PONV) refers to at least one nausea, retching or vomiting after operation, or any combination of the above symptoms. The incidence of PONV in high-risk patients can reach 61%-79%. PONV can not only cause dizziness and headache, but also cause disturbance of acid-base balance of water and electrolyte, wound dehiscence, formation of incisional hernia, aspiration, and aspiration pneumonia, leading to prolonged hospitalization, increased medical expenses, and reduced surgical satisfaction. At present, the guidelines for prevention and treatment of PONV and the consensus of experts suggest that identifying high-risk patients according to Apfel risk score ≥3 points, reducing baseline PONV risks, and implementing multimodal PONV prophylaxis. However, the incidence of PONV in high-risk patients is still as high as 20% even if 2-3 drugs are combined used for prevention and treatment. It is difficult to further reduce the incidence of PONV by adding different kinds or dosages of drugs, while drug-related side effects are increasing gradually. Acupuncture (electroacupuncture, transcutaneous electrical acupoint stimulationTEAS, transcutaneous electrical nerve stimulation, etc.) is a safe, effective, non-toxic side-effect non-drug treatment method. A large number of studies have confirmed that acupuncture can reduce the incidence of PONV, and it is expected to become an important supplement to drug treatment of PONV, but there are quality defects such as small sample size, inaccurate intervention and so on. At the same time, most acupuncture studies aim to compare the efficacy of PONV with drug therapy, without considering the clinical situation, using acupuncture treatment based on drug standard treatment to further reduce the incidence of PONV, thus limiting the clinical application value of acupuncture. On the basis of standardized drug prevention and treatment of PONV, TEAS will be used to further reduce the incidence of PONV and promote rapid recovery of patients. This study will strongly demonstrate that acupuncture can break through the bottleneck of drug treatment and provide evidence for the application of acupuncture in modern perioperative clinical medicine.

Detailed description: This study intends to carry out a high-quality clinical research with design specifications, large sample, multi-center, evaluator blinded, randomized and controlled methods. From September 1, 2019 to October 30, 2020, patients undergoing laparoscopic non-gastrointestinal surgery under general anesthesia will be recruited, based on the combination of dexamethasone and 5-HT3 antagonist, the efficacy of TEAS stimulation Neiguan (P6) and Zusanli (ST36) in the prevention and treatment of PONV will be verified. In TEAS group, bilateral P6 and ST36 TEAS intervention after removal tracheal intubation and on the first day after surgery, a total of 2 times, 30 minutes each time, 2/10 Hz low frequency sparse wave, 6-9 mA. The patients will be given maximum intensity stimulation at all points during the intervention.To ensure the blindness of the evaluator, the time of evaluation will be on the afternoon of the first and the second day, and the 30 days after the operation, and three evaluations will be made. The main indicators are the incidence of PONV 24 hours after operation, and the secondary indicators are the quantitative indicators of PONV and the indicators of rapid recovery after operation.

Eligibility criteria: Inclusion Criteria:

* Age 18-50 years old, BMI 15\~40kg/m2, ASAI-III;
* Laparoscopic non-gastrointestinal surgery under general anesthesia;
* Postoperative Nausea and Vomiting Apfel ≥3;
* Understand and sign an informed consent form and cooperate with the intervention and evaluation;

Exclusion Criteria:

* Pregnancy, lactation period;
* Taboos of transcutaneous electrical stimulation: skin allergy, damage, infection and itching at test acupoints; allergy to tape; pacemaker implanter;
* Identify/discriminate a history of alcohol, opioids or other drugs abuse;
* Admission to ICU after surgery;
* Participation in other clinical studies within 3 months before admission to this study;

Primary outcomes:
measure: Incidence of PONV within 24 hours
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: The first nausea
timeFrame: 24 hours after surgery
measure: The first nausea's Visual Analogue Scale
timeFrame: 24 hours after surgery
measure: The first vomiting
timeFrame: 24 hours after surgery
measure: The first vomiting's Visual Analogue Scale
timeFrame: 24 hours after surgery
measure: Total nausea frenquency in postoperative 24 hours
timeFrame: 24 hours after surgery
measure: The Visual Analogue Scale of nausea in postoperative 24 hours
timeFrame: 24 hours after surgery
measure: Total vomiting frenquency in postoperative 24 hours
timeFrame: 24 hours after surgery
measure: The Visual Analogue Scale of vomiting in postoperative 24 hours
timeFrame: 24 hours after surgery
measure: 40-itemquality of recovery score
timeFrame: 24 hours after surgery
measure: Postoperative PONV complications
timeFrame: 30 days after surgery
measure: Postoperative hospital stay
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian JiaotongUniversity
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian JiaotongUniversity
name: Qiang Wang, MD,PHD
role: STUDY_CHAIR
References:
citation: Gao W, Zhang L, Han X, Wei L, Fang J, Zhang X, Zhang J, Wang H, Zhou Q, Wang C, Chen W, Ni X, Yang L, Du R, Wang G, Liu B, Li Y, Zhang S, Wang Q. Transcutaneous Electrical Acupoint Stimulation Decreases the Incidence of Postoperative Nausea and Vomiting After Laparoscopic Non-gastrointestinal Surgery: A Multi-Center Randomized Controlled Trial. Front Med (Lausanne). 2022 Mar 14;9:766244. doi: 10.3389/fmed.2022.766244. eCollection 2022.