PONVNCT07515027
Electroacupuncture Plus 5-HT3 Receptor Inhibitor for PONV Prevention in High-Risk Patients Undergoing Thoracoscopic Lung Cancer Surgery
A study testing Prophylactic administration of dolasetron and Electroacupuncture in people with PONV, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This prospective, randomized controlled study aims to evaluate the efficacy and safety of electroacupuncture combined with 5-HT3 receptor inhibitor for preventing postoperative nausea and vomiting (PONV) in high-risk patients undergoing thoracoscopic lung cancer 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?
- Prophylactic administration of dolasetron and Electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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;
- American Society of Anesthesiologists (ASA) physical status I-III;
- Body mass index (BMI) 18-30 kg/m²;
- Scheduled for elective video-assisted thoracoscopic surgery (VATS) lobectomy, segmentectomy, or wedge resection;
- Expected to receive postoperative opioid analgesia, with an Apfel risk score ≥ 3;
- Normal pulmonary function, without severe cardiovascular, hepatic, or renal abnormalities;
- No infection around the acupuncture sites;
- Voluntary written informed consent provided by the subject.
Who cannot join
- Severe systemic diseases, such as cardiovascular, hepatic, or renal abnormalities, or poor pulmonary function;
- Subjects with cognitive dysfunction or psychological disorders;
- History of previous esophageal or gastric surgery;
- Hypersensitivity to acupuncture or any study medications;
- Severe infection or history of surgery around the acupuncture sites;
- Pregnant or lactating women;
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- Long-term opioid use;
- Conversion to open surgery;
- Acupuncture treatment received within 1 month prior to enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai
Deputy Chief Physician, +86-22200000, caixiaoyue2007@163.com
About this study
Official title: Electroacupuncture Combined With 5-HT3 Receptor Inhibitor for the Prevention of Postoperative Nausea and Vomiting in High-risk Patients Undergoing Thoracoscopic Surgery for Lung Cancer
This prospective, randomized controlled study aims to evaluate the efficacy and safety of electroacupuncture combined with 5-HT3 receptor inhibitor for preventing postoperative nausea and vomiting (PONV) in high-risk patients undergoing thoracoscopic lung cancer surgery. The primary outcome is the incidence of PONV within 24 hours after surgery.
Read the detailed description
Postoperative nausea and vomiting (PONV) is a common complication after thoracic surgery, especially in high-risk patients, which seriously affects postoperative recovery and quality of life. 5-HT3 receptor inhibitors are commonly used for PONV prophylaxis, but their efficacy is limited in some high-risk populations. Electroacupuncture has been shown to reduce PONV in clinical settings.
This study aims to investigate the safety and efficacy of electroacupuncture (EA) combined with 5-HT3 receptor inhibitor dolasetron in preventing nausea and vomiting in high-risk patients after video-assisted thoracoscopic (VATS) surgery. This is a prospective, randomized, sham-controlled, blinded study designed to enroll perioperative patients at high risk of postoperative nausea and vomiting (PONV) (with an Apfel score ≥ 3) who are scheduled to undergo video-assisted thoracoscopic surgery (VATS) for lung resection. Eligible patients will be randomly assigned to 2 sessions of EA or sham electroacupuncture (SA) during the perioperative time. All patients will receive prophylactic antiemetic medication of dolasetron and dexamethasone. The primary outcome will be the incidence of PONV within 24 hours after surgery. The secondary outcomes include the incidence of postoperative nausea (PON), postoperative vomiting (POV), or PONV at different time intervals within 48 hours after surgery (upon awakening, 6, 24, 48 hours postoperatively), severity of PON (assessed by Visual Analogue Scale, VAS score), frequency of POV, usage rate of rescue antiemetic drugs, average dosage intensity of opioids administered during and after surgery, average exhaust time and average defecation time; average length of hospital stay, and recording of adverse events related to acupuncture.
- Conditions
- PONV
- Being tested
- Prophylactic administration of dolasetron, Electroacupuncture, Sham electroacupuncture
- Keywords
- PONV, EA, VATS
- 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.
Prophylactic administration of dolasetronDrug
Dolasetron 12.5 mg is administered prior to the completion of surgery
ElectroacupunctureOther
EA is performed at two time points: 30 minutes before anesthesia induction and 4 hours postoperatively, with each session lasting 30 minutes. Bilateral acupoints including PC6, LI4, and ST36 are selected. Disposable stainless-steel needles are inserted through fixed insulating pads to a depth of approximately 10 mm. Manual manipulations are applied until deqi (the needling sensation) is achieved. An electroacupuncture device (Hwato SDZ-III) is connected for electrical stimulation.
Sham electroacupunctureOther
Sham electroacupuncture (SA) is performed using a non-therapeutic placebo acupuncture device (sham needle) at the same time points, acupoint locations as the EA group, paired with fixed insulating pads. The placebo needle mimics the appearance and tactile sensation of real needles without true skin penetration or therapeutic depth; no manual manipulation is conducted to achieve deqi, and no electrical stimulation is applied via the electroacupuncture device.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture (EA) group | Experimental | On the basis of receiving dolasetron and dexamethasone for preventing postoperative nausea and vomiting (PONV) during the perioperative period of video-assisted thoracoscopic surgery (VATS) for lung resection, the participants will receive electroacupuncture at 30 minutes before anesthesia induction and 4 hours after surgery. Receives: Drug: Prophylactic administration of dolasetron; Other: Electroacupuncture |
| sham electroacupuncture (SA) group | Sham comparator | On the basis of receiving dolasetron and dexamethasone for preventing postoperative nausea and vomiting (PONV) during the perioperative period of video-assisted thoracoscopic surgery (VATS) for lung resection, the participants will receive sham electroacupuncture at 30 minutes before anesthesia induction and 4 hours after surgery. Receives: Drug: Prophylactic administration of dolasetron; Other: Sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and vomiting (PONV) within 24 hours after surgery
Measured: within 24 hours postoperatively
Secondary outcomes (6)
Incidence of PON, POV, and PONV
Measured: within 48 hours postoperatively
Severity of PONV assessed by PONV VAS score
Severity of Postoperative Nausea and Vomiting (PONV) assessed by PONV VAS score (range 0-10; higher scores indicate more severe PONV)
Measured: within 48 hours postoperatively
Usage rate of rescue antiemetic medication
Measured: within 48 hours postoperatively
Sufentanil consumption during postoperative PCIA
Measured: within 48 hours postoperatively
Mean time to first postoperative flatus
Measured: From surgery to first postoperative flatus, up to 7 days postoperatively
Mean length of postoperative hospital stay
Measured: From surgery to hospital discharge, up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start7 Apr 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PONVStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cai Xiaoyue, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515027
- Sponsor's protocol ID
- IS25031
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Brief explanation for not sharing IPD: This study does not plan to share Individual Participant Data (IPD) primarily to protect the privacy and confidentiality of study participants, in line with the ethical requirements of clinical trials and the relevant policies of the Chinese Clinical Trial Registry. All participant-related data, including demographic data, baseline clinical data, intervention-related data, outcome measure data and follow-up data, are strictly managed and kept confidential.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture Combined With 5-HT3 Receptor Inhibitor for the Prevention of Postoperative Nausea and Vomiting in High-risk Patients Undergoing Thoracoscopic Surgery for Lung Cancer
- ClinicalTrials.gov ID
- NCT07515027
- Acronym / sponsor ID
- IS25031
- Conditions
- PONV
- Keywords
- PONV, EA, VATS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 7 Apr 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Apr 2026 (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.
This prospective, randomized controlled study aims to evaluate the efficacy and safety of electroacupuncture combined with 5-HT3 receptor inhibitor for preventing postoperative nausea and vomiting (PONV) in high-risk patients undergoing thoracoscopic lung cancer surgery. The primary outcome is the incidence of PONV within 24 hours after surgery.
Detailed description
Postoperative nausea and vomiting (PONV) is a common complication after thoracic surgery, especially in high-risk patients, which seriously affects postoperative recovery and quality of life. 5-HT3 receptor inhibitors are commonly used for PONV prophylaxis, but their efficacy is limited in some high-risk populations. Electroacupuncture has been shown to reduce PONV in clinical settings.
This study aims to investigate the safety and efficacy of electroacupuncture (EA) combined with 5-HT3 receptor inhibitor dolasetron in preventing nausea and vomiting in high-risk patients after video-assisted thoracoscopic (VATS) surgery. This is a prospective, randomized, sham-controlled, blinded study designed to enroll perioperative patients at high risk of postoperative nausea and vomiting (PONV) (with an Apfel score ≥ 3) who are scheduled to undergo video-assisted thoracoscopic surgery (VATS) for lung resection. Eligible patients will be randomly assigned to 2 sessions of EA or sham electroacupuncture (SA) during the perioperative time. All patients will receive prophylactic antiemetic medication of dolasetron and dexamethasone. The primary outcome will be the incidence of PONV within 24 hours after surgery. The secondary outcomes include the incidence of postoperative nausea (PON), postoperative vomiting (POV), or PONV at different time intervals within 48 hours after surgery (upon awakening, 6, 24, 48 hours postoperatively), severity of PON (assessed by Visual Analogue Scale, VAS score), frequency of POV, usage rate of rescue antiemetic drugs, average dosage intensity of opioids administered during and after surgery, average exhaust time and average defecation time; average length of hospital stay, and recording of adverse events related to acupuncture.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture (EA) group | Experimental | Drug: Prophylactic administration of dolasetron, Other: ElectroacupunctureOn the basis of receiving dolasetron and dexamethasone for preventing postoperative nausea and vomiting (PONV) during the perioperative period of video-assisted thoracoscopic surgery (VATS) for lung resection, the participants will receive electroacupuncture at 30 minutes before anesthesia induction and 4 hours after surgery. |
| sham electroacupuncture (SA) group | Sham comparator | Drug: Prophylactic administration of dolasetron, Other: Sham electroacupunctureOn the basis of receiving dolasetron and dexamethasone for preventing postoperative nausea and vomiting (PONV) during the perioperative period of video-assisted thoracoscopic surgery (VATS) for lung resection, the participants will receive sham electroacupuncture at 30 minutes before anesthesia induction and 4 hours after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years;
- American Society of Anesthesiologists (ASA) physical status I-III;
- Body mass index (BMI) 18-30 kg/m²;
- Scheduled for elective video-assisted thoracoscopic surgery (VATS) lobectomy, segmentectomy, or wedge resection;
- Expected to receive postoperative opioid analgesia, with an Apfel risk score ≥ 3;
Key exclusion criteria (9 listed)
- Severe systemic diseases, such as cardiovascular, hepatic, or renal abnormalities, or poor pulmonary function;
- Subjects with cognitive dysfunction or psychological disorders;
- History of previous esophageal or gastric surgery;
- Hypersensitivity to acupuncture or any study medications;
- Severe infection or history of surgery around the acupuncture sites;
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 |
|---|---|---|
| Prophylactic administration of dolasetronDolasetron 12.5 mg is administered prior to the completion of surgery | Drug | Electroacupuncture (EA) group, sham electroacupuncture (SA) group |
| ElectroacupunctureEA is performed at two time points: 30 minutes before anesthesia induction and 4 hours postoperatively, with each session lasting 30 minutes. Bilateral acupoints including PC6, LI4, and ST36 are selected. Disposable stainless-steel needles are inserted through fixed insulating pads to a depth of approximately 10 mm. Manual manipulations are applied until deqi (the needling sensation) is achieved. An electroacupuncture device (Hwato SDZ-III) is connected for electrical stimulation. | Other | Electroacupuncture (EA) group |
| Sham electroacupunctureSham electroacupuncture (SA) is performed using a non-therapeutic placebo acupuncture device (sham needle) at the same time points, acupoint locations as the EA group, paired with fixed insulating pads. The placebo needle mimics the appearance and tactile sensation of real needles without true skin penetration or therapeutic depth; no manual manipulation is conducted to achieve deqi, and no electrical stimulation is applied via the electroacupuncture device. | Other | sham electroacupuncture (SA) group |
Primary outcome
Incidence of postoperative nausea and vomiting (PONV) within 24 hours after surgery
Time frame: within 24 hours postoperatively
6 secondary outcomes
Incidence of PON, POV, and PONV
Time frame: within 48 hours postoperatively
Severity of PONV assessed by PONV VAS score
Time frame: within 48 hours postoperatively
Usage rate of rescue antiemetic medication
Time frame: within 48 hours postoperatively
Sufentanil consumption during postoperative PCIA
Time frame: within 48 hours postoperatively
Mean time to first postoperative flatus
Time frame: From surgery to first postoperative flatus, up to 7 days postoperatively
Mean length of postoperative hospital stay
Time frame: From surgery to hospital discharge, up to 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. Brief explanation for not sharing IPD: This study does not plan to share Individual Participant Data (IPD) primarily to protect the privacy and confidentiality of study participants, in line with the ethical requirements of clinical trials and the relevant policies of the Chinese Clinical Trial Registry. All participant-related data, including demographic data, baseline clinical data, intervention-related data, outcome measure data and follow-up data, are strictly managed and kept confidential.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic administration of dolasetron and Electroacupuncture in people with PONV, run by Shanghai Chest Hospital 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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deputy Chief Physician (+86 18017321631, caixiaoyue2007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative nausea and vomiting (PONV) within 24 hours after surgery (time frame: within 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.