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

NCT07515027 | Recruiting

• 1 other identifier: IS25031
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PONV

Keywords

PONV; EA; VATS

Outcome Measures

Primary Outcomes (1)

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

  within 24 hours postoperatively

Secondary Outcomes (6)

• Incidence of PON, POV, and PONV

  within 48 hours postoperatively

• Severity of PONV assessed by PONV VAS score

  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

Other Outcomes (1)

• 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

Study Arms (2)

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.

Drug: Prophylactic administration of dolasetron; Other: Electroacupuncture

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.

Drug: Prophylactic administration of dolasetron; Other: Sham electroacupuncture

Interventions

Prophylactic administration of dolasetron DRUG

Dolasetron 12.5 mg is administered prior to the completion of surgery

Electroacupuncture (EA) group; sham electroacupuncture (SA) group

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.

Electroacupuncture (EA) group

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.

sham electroacupuncture (SA) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Central Study Contacts

Deputy Chief Physician

CONTACT

+86 18017321631; caixiaoyue2007@163.com

Chief Physician

CONTACT

+86 18017320233; gason2000@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)