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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: A Single-blind, Randomized, Placebo-controlled Clinical Trial
Sponsor: Shanghai Chest Hospital
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
204
Start Date
2026-03-30
Completion Date
2026-12-31
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
Prophylactic administration of dolasetron and dexamethasone combined with electroacupuncture or sham electroacupuncture
This randomized controlled intervention targets postoperative nausea and vomiting (PONV) prophylaxis, combining standardized antiemetic therapy with either electroacupuncture (EA) or sham electroacupuncture (SA). Experimental Group (EA) EA is delivered 30 minutes pre-induction and 4 hours post-surgery (30 minutes/session). Bilateral PC6, LI4, Zusanli acupoints are used. Disposable stainless-steel needles (0.3×40 mm) are inserted 10 mm deep via insulating pads. Manual manipulations are applied to elicit deqi. An Hwato SDZ-III electroacupuncture device provides continuous wave stimulation (2-20 Hz, 0.1-1 mA, patient-tolerated, \<10 mA). Control Group (SA) SA uses non-therapeutic placebo acupuncture needles (sham device) at identical time points and acupoints, with matching insulating pads. Placebo needles mimic real needles without true penetration; no deqi manipulations or electrical stimulation are applied, replicating EA procedure without therapeutic effects.
Locations (1)
Shanghai Chest Hospital
Shanghai, China