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

Обзор

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.

Подробное описание

Postoperative nausea and vomiting (PONV) are common and debilitating complications that can occur after surgery. Their incidence is estimated to be around 30% in the general population and may reach up to 80% in high-risk patients in the absence of prevention, thus constituting a frequent and major source of dissatisfaction. In outpatient surgery, it is still assumed that postoperative outcomes are straightforward. However, this perception is based on a bias of ignorance, as postoperative outcomes are rarely measured after hospital discharge. However, recent studies suggest that nearly 40% of patients may present with PONV once at home. The symptoms are sometimes considered more debilitating than the postoperative pain itself. Although rarely serious, they have a considerable impact on patient satisfaction and the length of their recovery. In some studies, they even represent the main cause of readmission after outpatient surgery or failure of discharge, resulting in additional costs for the healthcare system.

This study aims to evaluate if the addition of 40 mg aprepitant to a multimodal strategy for preventing post operative nausea and vomitting improves clinical outcomes in high-risk patients undergoing outpatient surgery.

The primary objective of this study is to evaluate the complete response rate, defined as the absence of nausea, vomiting, or the need for rescue treatment within 48 hours following surgery.

Вмешательства

• Препарат Aprepitant 40mg
  Just before the patient is taken to the operating room, a single oral capsule of 40 mg of aprepitant will be given to the participant to evaluate the effectiveness of 40 mg of aprepitant in preventing postoperative nausea and vomiting (PONV) in outpatient surgery. The protocol was chosen to determine whether adding aprepitant to a standard multimodal strategy provides a clinically measurable benefit compared to placebo.
• Препарат Placebo
  Just before the patient is taken to the operating room, a single oral capsule of 40 mg of placebo will be given to the participant.

Первичные конечные точки

• Rate of complete response according to postoperative nausea and vomitting [Срок оценки: 48 hours after the surgery]

Вторичные конечные точки (6)

• Severity and frequence of nausea and vomiting [Срок оценки: At discharge from recovery room, usually 1h after the end of the surgery, 24 hours and 48 hours after the surgery]
• Medical economic impact [Срок оценки: 48 hours after the surgery]
• Quality of recovery [Срок оценки: Change between baseline (before surgery) and 48 hours after the surgery]
• Incidence of side effects [Срок оценки: 48 hours after the surgery]
• Patient satisfaction [Срок оценки: 48 hours after the surgery]
• Analgesic consumptions (Opioid and non opioid) [Срок оценки: 48 hours after the surgery]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Канада · 1 центр

• Centre hospitalier de l'Université de Montréal (CHUM) — Montreal

Идентификаторы

NCT: NCT07248280 · 2026-13145

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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