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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic administration of dolasetron | Drug | Dolasetron 12.5 mg is administered prior to the completion of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative nausea and vomiting (PONV) within 24 hours after surgery | within 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of PON, POV, and PONV | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events related to acupuncture | From the start of acupuncture intervention until 7 days after the last acupuncture session, or until hospital discharge, whichever occurs later |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deputy Chief Physician | Contact | +86 18017321631 | caixiaoyue2007@163.com | |
| Chief Physician | Contact | +86 18017320233 | gason2000@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | China |
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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The clinical trial coordinators and acupuncturists are aware of the treatment assignments; while the subjects, anesthesiologists, perioperative management physicians, baseline and efficacy assessors, and statistical analysts are all blinded.
| Electroacupuncture | Other | 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. |
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| Sham electroacupuncture | Other | 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. |
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| within 48 hours postoperatively |
| Usage rate of rescue antiemetic medication | within 48 hours postoperatively |
| Sufentanil consumption during postoperative PCIA | within 48 hours postoperatively |
| Mean time to first postoperative flatus | From surgery to first postoperative flatus, up to 7 days postoperatively |
| Mean length of postoperative hospital stay | From surgery to hospital discharge, up to 30 days postoperatively |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D004599 | Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |
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