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

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

Overview

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.

Interventions

• Drug Prophylactic administration of dolasetron
  Dolasetron 12.5 mg is administered prior to the completion of surgery
• Other Electroacupuncture
  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.
• Other Sham electroacupuncture
  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 outcome measures

• Incidence of postoperative nausea and vomiting (PONV) within 24 hours after surgery [Time frame: within 24 hours postoperatively]

Secondary outcome measures (6)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

China · 1 center

• Shanghai Chest Hospital — Shanghai

Identifiers

NCT: NCT07515027 · IS25031

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗