ArticleTrials2025
Effects of penehyclidine hydrochloride on postoperative nausea and vomiting in patients who underwent radical thoracoscopic lung cancer surgery: study protocol for a single-center, prospective, randomized controlled clinical trial.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundPostoperative nausea and vomiting (PONV) is a common complication of surgical procedures, especially of radical thoracoscopic lung cancer surgery, and causes patient discomfort, delays recovery, and increases healthcare costs. Penehyclidine hydrochloride (PHC), a novel anticholinergic agent, can potentially reduce surgery- and anesthesia-related adverse reactions such as PONV, possibly because of its selective M
methodsThis single-center, prospective, double-blind, randomized controlled clinical trial will include 446 patients scheduled for radical thoracoscopic lung cancer surgery. Enrolled participants will be randomly assigned to a test or control group in a 1:1 ratio, with 223 patients in each group. The test group will receive an intravenous injection of 0.25 mg PHC before anesthesia and an intravenous infusion of 0.25 mg PHC within 48 h after surgery, whereas the control group will receive normal saline instead of PHC. The primary outcome will be the incidence of PONV within 24 h post-surgery. Secondary outcomes will include the incidence and severity of PONV within different time intervals (0-6, 6-12, and 12-24 h post-surgery); surgeon and patient satisfaction levels at 48 h post-surgery, rated using a visual analog scale; and the occurrence of dry mouth, dizziness, red face, dry skin, urinary retention, delirium, and hyperthermia within 48 h post-surgery. An intention-to-treat analysis will be performed. DISCUSSION: We hypothesize that administration of intravenous PHC can reduce the incidence and severity of PONV and improve surgeon and patient satisfaction. The findings of this trial could have important implications for improving patient outcomes and optimizing postoperative care for patients who undergo radical thoracoscopic lung cancer surgery.
trial registrationThis trial protocol was registered in the Chinese Clinical Trial Registry on April 19, 2024 (registration number: ChiCTR2400083262).
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