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

ConditionPONV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Chest Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prophylactic administration of dolasetron

    Drug

    Dolasetron 12.5 mg is administered prior to the completion of surgery

  • Electroacupuncture

    Other intervention

    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 intervention

    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.

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: Electroacupuncture (EA) groupExperimental treatment 2 interventions
Group B: sham electroacupuncture (SA) groupSham comparator 2 interventions

Trial outcomes

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

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

Time frame
within 48 hours postoperatively
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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Chest Hospital

Lead sponsor

Source ClinicalTrials.gov
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