Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting: a Multicenter, Evaluator-Blind, Randomized and Controlled Study

Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting

Sponsors

Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University

Source First Affiliated Hospital Xi'an Jiaotong University
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%-78%. 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 based on preoperative evaluation of PONV risk grading, using layer-by-layer classification therapy, increasing the types of anti-emetic drugs. 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 June 15, 2019 to June 15, 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.

Overall Status Recruiting
Start Date July 15, 2019
Completion Date July 15, 2020
Primary Completion Date July 15, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of PONV within 24 hours 24 hours after surgery
Secondary Outcome
Measure Time Frame
The first nausea 24 hours after surgery
The first nausea's Visual Analogue Scale 24 hours after surgery
The first vomiting 24 hours after surgery
The first vomiting's Visual Analogue Scale 24 hours after surgery
Total nausea frenquency in postoperative 24 hours 24 hours after surgery
The Visual Analogue Scale of nausea in postoperative 24 hours 24 hours after surgery
Total vomiting frenquency in postoperative 24 hours 24 hours after surgery
The Visual Analogue Scale of vomiting in postoperative 24 hours 24 hours after surgery
40-itemquality of recovery score 24 hours after surgery
Postoperative PONV complications 30 days after surgery
Postoperative hospital stay 30 days after surgery
Enrollment 10000
Condition
Intervention

Intervention type: Device

Intervention name: TEAS

Description: Bilateral Neiguan and Zusanli acupuncture points, 2/10Hz Dense wave , 6-9mA,30min

Arm group label: TEAS Group

Intervention type: Device

Intervention name: TEAS without electrical stimulation

Description: Bilateral Neiguan and Zusanli acupuncture points, with no electrical stimulation

Arm group label: Control Group

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;

Gender: All

Minimum age: 18 Years

Maximum age: 50 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Qiang Wang, MD,PHD Study Chair First Affiliated Hospital of Xian JiaotongUniversity
Overall Contact

Last name: Qiang Wang, MD,PHD

Phone: 0086-18049286968

Email: [email protected]

Location
facility status contact
First Affiliated Hospital of Xian JiaotongUniversity Recruiting Qiang Wang, PHD 0086-18049286968 [email protected]
Location Countries

China

Verification Date

July 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Control Group

Arm group type: Sham Comparator

Description: Same as TEAS group but without electrical stimulation

Arm group label: TEAS Group

Arm group type: Experimental

Description: Bilateral Neiguan and Zusanli acupuncture points, 2/10Hz Dense wave , 6-9mA,30min

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov