Postoperative Nausea and VomitingNCT04043247
Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting
A study testing TEAS and TEAS without electrical stimulation in people with Postoperative Nausea and Vomiting, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- TEAS and TEAS without electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,655 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2019to 9 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xian JiaotongUniversity
Xi'an, Shaanxi, 029710061
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- TEAS, TEAS without electrical stimulation
- Keywords
- Postoperative Nausea and Vomiting;TEAS
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEASDevice
Bilateral Neiguan and Zusanli acupuncture points, 2/10Hz Dense wave , 6-9mA,30min
TEAS without electrical stimulationDevice
Bilateral Neiguan and Zusanli acupuncture points, with no electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Sham comparator | Same as TEAS group but without electrical stimulation Receives: Device: TEAS without electrical stimulation |
| TEAS Group | Experimental | Bilateral Neiguan and Zusanli acupuncture points, 2/10Hz Dense wave , 6-9mA,30min Receives: Device: TEAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PONV within 24 hours
Whether or not nausea or vomiting happens
Measured: 24 hours after surgery
Secondary outcomes (11)
The first nausea
the time point of the first nausea.
Measured: 24 hours after surgery
The first nausea's Visual Analogue Scale
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.
Measured: 24 hours after surgery
The first vomiting
the time point the first vomiting
Measured: 24 hours after surgery
The first vomiting's Visual Analogue Scale
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.
Measured: 24 hours after surgery
Total nausea frenquency in postoperative 24 hours
the total nausea times of the subjects
Measured: 24 hours after surgery
The Visual Analogue Scale of nausea in postoperative 24 hours
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.
Measured: 24 hours after surgery
Total vomiting frenquency in postoperative 24 hours
the total vomiting times of the subjects
Measured: 24 hours after surgery
The Visual Analogue Scale of vomiting in postoperative 24 hours
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.
Measured: 24 hours after surgery
40-itemquality of recovery score
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).
Measured: 24 hours after surgery
Postoperative PONV complications
The incidence of dizziness, headache, electrolyte imbalance, aspiration, aspiration pneumonia, and wound dehiscence
Measured: 30 days after surgery
Postoperative hospital stay
The interval between the date of discharge and the date of surgery.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start3 Sep 2019
- Primary completion9 Nov 2020
- Study completion9 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,655 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang Wang, MD,PHD, Study chair, First Affiliated Hospital of Xian JiaotongUniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043247
- Sponsor's protocol ID
- XJTU1AF2019LSK-084
- Status last verified
- Dec 2020
- First submitted
- 29 Jul 2019
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35360742
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting: a Multicenter, Evaluator-Blind, Randomized and Controlled Study
- ClinicalTrials.gov ID
- NCT04043247
- Acronym / sponsor ID
- XJTU1AF2019LSK-084
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Postoperative Nausea and Vomiting;TEAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,655 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Sham comparator | Device: TEAS without electrical stimulationSame as TEAS group but without electrical stimulation |
| TEAS Group | Experimental | Device: TEASBilateral Neiguan and Zusanli acupuncture points, 2/10Hz Dense wave , 6-9mA,30min |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEASBilateral Neiguan and Zusanli acupuncture points, 2/10Hz Dense wave , 6-9mA,30min | Device | TEAS Group |
| TEAS without electrical stimulationBilateral Neiguan and Zusanli acupuncture points, with no electrical stimulation | Device | Control Group |
Primary outcome
Incidence of PONV within 24 hours
Time frame: 24 hours after surgery
Whether or not nausea or vomiting happens
11 secondary outcomes
The first nausea
Time frame: 24 hours after surgery
The first nausea's Visual Analogue Scale
Time frame: 24 hours after surgery
The first vomiting
Time frame: 24 hours after surgery
The first vomiting's Visual Analogue Scale
Time frame: 24 hours after surgery
Total nausea frenquency in postoperative 24 hours
Time frame: 24 hours after surgery
The Visual Analogue Scale of nausea in postoperative 24 hours
Time frame: 24 hours after surgery
Total vomiting frenquency in postoperative 24 hours
Time frame: 24 hours after surgery
The Visual Analogue Scale of vomiting in postoperative 24 hours
Time frame: 24 hours after surgery
40-itemquality of recovery score
Time frame: 24 hours after surgery
Postoperative PONV complications
Time frame: 30 days after surgery
Postoperative hospital stay
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Derived from this study: PubMed 35360742Gao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiang Wang, MD,PHD study chair
First Affiliated Hospital of Xian JiaotongUniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAS and TEAS without electrical stimulation in people with Postoperative Nausea and Vomiting, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PONV within 24 hours (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04043247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.