PONVNCT05396716
Acupoint Stimulation Alleviates Postoperative Nausea and Vomiting
A study testing transcutaneous electrical acupoint stimulation in people with PONV, run by Zhihong LU.
Trial summary
Incidence of postoperative nausea and vomiting (PONV) could be high as 60% after liver surgery. Acupoint stimulation has been proved to decrease PONV. In this study, we will investigate the effect of transcutaneous electrical acupoint stimulation on incidence of PONV after liver surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PONV
- What is being tested?
- transcutaneous electrical acupoint stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2022to 30 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years
- scheduled for elective liver surgery under general anesthesia
Who cannot join
- body mass index less than 18 kg/m2 or higher than 30 kg/m2
- American Society of Anesthesiologists status higher than Ⅲ
- patients with contraindication to transcutaneous electrical stimulation, including skin damage, infection or implantable electrical device
- suspected or existed abuse of drug or alcohol
- pregnant or breeding women
- history of neurological or psychiatric disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Nausea and Vomiting After Liver Surgery
Incidence of postoperative nausea and vomiting (PONV) could be high as 60% after liver surgery. Acupoint stimulation has been proved to decrease PONV. In this study, we will investigate the effect of transcutaneous electrical acupoint stimulation on incidence of PONV after liver surgery.
- Conditions
- PONV
- Being tested
- transcutaneous electrical acupoint stimulation
- Keywords
- transcutaneous electrical acupoint stimulation, liver surgery
- 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.
transcutaneous electrical acupoint stimulationDevice
Also called TEAS
Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous electrical acupoint stimulation | Experimental | Not described Receives: Device: transcutaneous electrical acupoint stimulation |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of nausea and vomiting by 24 hours after surgery
Measured: from end of surgery to 24 hours after surgery, in a total of 24 hours
Secondary outcomes (9)
incidence of nausea and vomiting by 48 hours after surgery
Measured: from end of surgery to 48 hours after surgery, in a total of 48 hours
incidence of nausea and vomiting in PACU (post-anesthesia care unit)
Measured: from end of surgery to discharge from PACU(post-anesthesia care unit), in an average of 30 minutes
score of nausea and vomiting by 24 hours after surgery
Measured: from end of surgery to 24 hours after surgery, in a total of 24 hours
score of nausea and vomiting by 48 hours after surgery
Measured: from end of surgery to 48 hours after surgery, in a total of 48 hours
score of nausea and vomiting in PACU(post-anesthesia care unit)
Measured: from end of surgery to discharge from PACU, in an average of 30 minutes
Quality of recovery score at 24 hours after surgery
Measured: from end of surgery to 24 hours after surgery, in a total of 24 hours
Quality of recovery score at 48 hours after surgery
Measured: from end of surgery to 48 hours after surgery, in a total of 48 hours
postoperative in-hospital stay
Measured: from end of surgery to discharge from hospital, in an average of 7 days
death by 6 months after surgery
Measured: from end of surgery to 6 months after surgery, in a total of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start30 May 2022 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PONVStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhihong LU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396716
- Sponsor's protocol ID
- XJH-A-20220410
- Status last verified
- May 2022
- First submitted
- 25 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee A, Chan SK, Fan LT. Stimulation of the wrist acupuncture point PC6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2015 Nov 2;2015(11):CD003281. doi: 10.1002/14651858.CD003281.pub4.
PubMed 26522652He S, Lv Z, Wang H, Yu N, Tuo X, Wang Y, Dong H, Cao J, Wang Y, Lu Z. Acupoint Stimulation After Anesthesia Induction Does Not Decrease Nausea and Vomiting After Hepatectomy: A Multi-Center Double-Blinded Clinical Trial. J Invest Surg. 2026 Dec;39(1):2653912. doi: 10.1080/08941939.2026.2653912. Epub 2026 Apr 20.
PubMed 42003699
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Nausea and Vomiting After Liver Surgery
- ClinicalTrials.gov ID
- NCT05396716
- Acronym / sponsor ID
- XJH-A-20220410
- Conditions
- PONV
- Keywords
- transcutaneous electrical acupoint stimulation, liver surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Zhihong LUUniversity, hospital or other
- Study start
- 30 May 2022 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 31 May 2022 (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.
Incidence of postoperative nausea and vomiting (PONV) could be high as 60% after liver surgery. Acupoint stimulation has been proved to decrease PONV. In this study, we will investigate the effect of transcutaneous electrical acupoint stimulation on incidence of PONV after liver surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcutaneous electrical acupoint stimulation | Experimental | Device: transcutaneous electrical acupoint stimulation |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥18 years
- scheduled for elective liver surgery under general anesthesia
Key exclusion criteria (6 listed)
- body mass index less than 18 kg/m2 or higher than 30 kg/m2
- American Society of Anesthesiologists status higher than Ⅲ
- patients with contraindication to transcutaneous electrical stimulation, including skin damage, infection or implantable electrical device
- suspected or existed abuse of drug or alcohol
- pregnant or breeding women
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 |
|---|---|---|
| transcutaneous electrical acupoint stimulationAlso: TEASElectrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery. | Device | transcutaneous electrical acupoint stimulation |
Primary outcome
incidence of nausea and vomiting by 24 hours after surgery
Time frame: from end of surgery to 24 hours after surgery, in a total of 24 hours
9 secondary outcomes
incidence of nausea and vomiting by 48 hours after surgery
Time frame: from end of surgery to 48 hours after surgery, in a total of 48 hours
incidence of nausea and vomiting in PACU (post-anesthesia care unit)
Time frame: from end of surgery to discharge from PACU(post-anesthesia care unit), in an average of 30 minutes
score of nausea and vomiting by 24 hours after surgery
Time frame: from end of surgery to 24 hours after surgery, in a total of 24 hours
score of nausea and vomiting by 48 hours after surgery
Time frame: from end of surgery to 48 hours after surgery, in a total of 48 hours
score of nausea and vomiting in PACU(post-anesthesia care unit)
Time frame: from end of surgery to discharge from PACU, in an average of 30 minutes
Quality of recovery score at 24 hours after surgery
Time frame: from end of surgery to 24 hours after surgery, in a total of 24 hours
Quality of recovery score at 48 hours after surgery
Time frame: from end of surgery to 48 hours after surgery, in a total of 48 hours
postoperative in-hospital stay
Time frame: from end of surgery to discharge from hospital, in an average of 7 days
death by 6 months after surgery
Time frame: from end of surgery to 6 months after surgery, in a total of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Background: PubMed 26522652Lee A, Chan SK, Fan LT. Stimulation of the wrist acupuncture point PC6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2015 Nov 2;2015(11):CD003281. doi: 10.1002/14651858.CD003281.pub4.
- Derived from this study: PubMed 42003699He S, Lv Z, Wang H, Yu N, Tuo X, Wang Y, Dong H, Cao J, Wang Y, Lu Z. Acupoint Stimulation After Anesthesia Induction Does Not Decrease Nausea and Vomiting After Hepatectomy: A Multi-Center Double-Blinded Clinical Trial. J Invest Surg. 2026 Dec;39(1):2653912. doi: 10.1080/08941939.2026.2653912. Epub 2026 Apr 20.
- Individual participant dataSharing planned: No
Related trials for PONV
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
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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.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical acupoint stimulation in people with PONV, run by Zhihong LU.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhihong Lu (+8613891975018, deerlu23@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of nausea and vomiting by 24 hours after surgery (time frame: from end of surgery to 24 hours after surgery, in a total of 24 hours). 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 NCT05396716, which also lists 2 linked publications.
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 31 May 2022.