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Recruiting Phase 3 NCT07248280

NCT07248280 Adding Aprepitant to a Multimodal Strategy for the Prevention of Postoperative Nausea and Vomiting in High-risk Outpatient Surgical Patients

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Clinical Trial Summary
NCT ID NCT07248280
Status Recruiting
Phase Phase 3
Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Condition Nausea and Vomiting, Postoperative
Study Type INTERVENTIONAL
Enrollment 260 participants
Start Date 2026-02-27
Primary Completion 2026-07-01

Trial Parameters

Condition Nausea and Vomiting, Postoperative
Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 260
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-02-27
Completion 2026-07-01
Interventions
Aprepitant 40mgPlacebo

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Brief Summary

Postoperative nausea and vomiting (PONV) are a frequent and debilitating complications after surgery, affecting up to 80% of patients at high risk in the absence of prophylaxis. Despite the rigorous application of the recommendations from the American Society of Anesthesiologists (ASA) at CHUM, a recent local study reveals a prevalence of 25% PONV at home after outpatient surgery. However, the therapeutic options at home remain limited. This study aims to evaluate if the addition of 40 mg aprepitant to a multimodal strategy for preventing PONV improves clinical outcomes in high-risk patients undergoing outpatient surgery.

Eligibility Criteria

Inclusion Criteria: * 18 years and over, requiring an ambulatory surgery * at high risk of post-operative nausea and vomitting defined by at least 3 factors from the Apfel score, calculated just prior to the surgery (female sex; non smoker; previous nausea or vomitting post-op., or motion sickness; expected opioid consumption in postoperative care). Exclusion Criteria: * Refusal or unable to consent * Suspected or documented allergy to aprepitant (emend) * Concomitant use of medication interacting via the cytochrome CYP3A4 with aprepitant (pimozide, terfenadine, astemizole, comtadin or cisapride).

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