- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04043247
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
1655
Phase
- 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
-
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Shaanxi
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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
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 |
Intervention / Treatment |
---|---|
Sham Comparator: Control Group
Same as TEAS group but 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
|
Bilateral Neiguan and Zusanli acupuncture points, 2/10Hz Dense wave , 6-9mA,30min
|
What is the study measuring?
Primary Outcome Measures
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
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.
Investigators
- 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.
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)
September 3, 2019
Primary Completion (Actual)
November 9, 2020
Study Completion (Actual)
December 9, 2020
Study Registration Dates
First Submitted
July 29, 2019
First Submitted That Met QC Criteria
July 31, 2019
First Posted (Actual)
August 2, 2019
Study Record Updates
Last Update Posted (Actual)
August 18, 2021
Last Update Submitted That Met QC Criteria
August 17, 2021
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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