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

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.

Study Overview

• Status: Recruiting
• Conditions: PONV
• Intervention / Treatment: Drug: Prophylactic administration of dolasetron; Other: Electroacupuncture; Other: Sham electroacupuncture

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 Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deputy Chief Physician; Phone Number: +86 18017321631; Email: caixiaoyue2007@163.com
• Study Contact Backup: Name: Chief Physician; Phone Number: +86 18017320233; Email: gason2000@126.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Chest Hospital
    • Contact: Deputy Chief Physician; Phone Number: +86-22200000; Email: caixiaoyue2007@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroacupuncture (EA) group; 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.	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.
Sham Comparator: sham electroacupuncture (SA) group; 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.	Drug: Prophylactic administration of dolasetron; Dolasetron 12.5 mg is administered prior to the completion of surgery; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of postoperative nausea and vomiting (PONV) within 24 hours after surgery	within 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of PON, POV, and PONV		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
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)	within 48 hours postoperatively

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 7, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: PONV; VATS; EA
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Postoperative Nausea and Vomiting; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Combined Modality Therapy; Anesthesia; Analgesia; Acupuncture Therapy; Transcutaneous Electric Nerve Stimulation; Electroacupuncture
• Other Study ID Numbers: IS25031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No