Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting

August 17, 2021 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1655

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 029710061
        • First Affiliated Hospital of Xian JiaotongUniversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Control Group
Same as TEAS group but without electrical stimulation
Device: TEAS without electrical stimulation
Bilateral Neiguan and Zusanli acupuncture points, with no electrical stimulation
Experimental: TEAS Group
Bilateral Neiguan and Zusanli acupuncture points, 2/10Hz Dense wave , 6-9mA,30min
Device: TEAS
Bilateral Neiguan and Zusanli acupuncture points, 2/10Hz Dense wave , 6-9mA,30min

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of PONV within 24 hours
Time Frame: 24 hours after surgery
Whether or not nausea or vomiting happens
24 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The first nausea
Time Frame: 24 hours after surgery
the time point of the first nausea.
24 hours after surgery
The first nausea's Visual Analogue Scale
Time Frame: 24 hours after surgery
the Visual Analogue Scale of the first nausea : the Visual Analog Scale (VAS) is a 10 cm line with anchor statements ，on the left (no nausea) and on the right (extreme nausea). The patient is asked to mark their current nausea level on the line. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no nausea" anchor point.
24 hours after surgery
The first vomiting
Time Frame: 24 hours after surgery
the time point the first vomiting
24 hours after surgery
The first vomiting's Visual Analogue Scale
Time Frame: 24 hours after surgery
the Visual Analogue Scale of the first vomiting : the Visual Analog Scale (VAS) is a 10 cm line with anchor statements ，on the left (no vomitting) and on the right (extreme vomiting). The patient is asked to mark their current vomiting level on the line. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no vomiting" anchor point.
24 hours after surgery
Total nausea frenquency in postoperative 24 hours
Time Frame: 24 hours after surgery
the total nausea times of the subjects
24 hours after surgery
The Visual Analogue Scale of nausea in postoperative 24 hours
Time Frame: 24 hours after surgery
the Visual Analogue Scale of nausea in postoperative 24 hours : the Visual Analog Scale (VAS) is a 10 cm line with anchor statements ，on the left (no nausea) and on the right (extreme nausea). The patient is asked to mark their current nausea level on the line. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no nausea" anchor point.
24 hours after surgery
Total vomiting frenquency in postoperative 24 hours
Time Frame: 24 hours after surgery
the total vomiting times of the subjects
24 hours after surgery
The Visual Analogue Scale of vomiting in postoperative 24 hours
Time Frame: 24 hours after surgery
the Visual Analogue Scale of vomiting in postoperative 24 hours : the Visual Analog Scale (VAS) is a 10 cm line with anchor statements ，on the left (no vomitting) and on the right (extreme vomiting). The patient is asked to mark their current vomiting level on the line. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no vomiting" anchor point.
24 hours after surgery
40-itemquality of recovery score
Time Frame: 24 hours after surgery
The quality of postoperative life recovery was assessed by questionnaire. The content mainly included five aspects, physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items) and pain (7 items).
24 hours after surgery
Postoperative PONV complications
Time Frame: 30 days after surgery
The incidence of dizziness, headache, electrolyte imbalance, aspiration, aspiration pneumonia, and wound dehiscence
30 days after surgery
Postoperative hospital stay
Time Frame: 30 days after surgery
The interval between the date of discharge and the date of surgery.
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Qiang Wang, MD,PHD, First Affiliated Hospital of Xian JiaotongUniversity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 9, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XJTU1AF2019LSK-084

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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