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NCT Number: NCT07515027

Electroacupuncture Plus 5-HT3 Receptor Inhibitor for PONV Prevention in High-Risk Patients Undergoing Thoracoscopic Lung Cancer Surgery

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Long-term opioid use;
  • Conversion to open surgery;
  • Acupuncture treatment received within 1 month prior to enrollment.

Treatment and study plan

Prophylactic administration of dolasetron

Drug

Dolasetron 12.5 mg is administered prior to the completion of surgery

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.

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.

Primary outcomes

  1. Incidence of postoperative nausea and vomiting (PONV) within 24 hours after surgery

    Time frame: within 24 hours postoperatively

Secondary outcomes

  1. Incidence of PON, POV, and PONV

    Time frame: within 48 hours postoperatively

  2. Severity of PONV assessed by PONV VAS score

    Time frame: within 48 hours postoperatively

    Severity of Postoperative Nausea and Vomiting (PONV) assessed by PONV VAS score (range 0-10; higher scores indicate more severe PONV)

  3. Usage rate of rescue antiemetic medication

    Time frame: within 48 hours postoperatively

  4. Sufentanil consumption during postoperative PCIA

    Time frame: within 48 hours postoperatively

  5. Mean time to first postoperative flatus

    Time frame: From surgery to first postoperative flatus, up to 7 days postoperatively

  6. Mean length of postoperative hospital stay

    Time frame: From surgery to hospital discharge, up to 30 days postoperatively

Other outcomes

  1. Incidence of adverse events related to acupuncture

    Time frame: From the start of acupuncture intervention until 7 days after the last acupuncture session, or until hospital discharge, whichever occurs later

Study contacts

Contact information is provided by the study sponsor or research team.

Chief Physician

CONTACT

[email protected]

+86 18017320233

Deputy Chief Physician

CONTACT

[email protected]

+86 18017321631

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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