Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting

NCT04043247 | Completed DMC

• 1 other identifier: XJTU1AF2019LSK-084
• Study Type: interventional
• Target: 1,655
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative Nausea and Vomiting;TEAS

Outcome Measures

Primary Outcomes (1)

• Incidence of PONV within 24 hours

  Whether or not nausea or vomiting happens

  24 hours after surgery

Secondary Outcomes (11)

• 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

Study Arms (2)

Control Group

SHAM COMPARATOR

Same as TEAS group but without electrical stimulation

Device: TEAS without electrical stimulation

TEAS Group

EXPERIMENTAL

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

Device: TEAS

Interventions

TEAS DEVICE

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

TEAS Group

TEAS without electrical stimulation DEVICE

Bilateral Neiguan and Zusanli acupuncture points, with no electrical stimulation

Control Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, 029710061, China

Location

Related Publications (1)

• 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.

  PMID: 35360742 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Qiang Wang, MD,PHD

  First Affiliated Hospital of Xian JiaotongUniversity

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 2, 2019
• Study Start: September 3, 2019
• Primary Completion: November 9, 2020
• Study Completion: December 9, 2020
• Last Updated: August 18, 2021

Record last verified: 2020-12

Locations

CN (1)