Adding Aprepitant to a Multimodal Strategy for the Prevention of Postoperative Nausea and Vomiting in High-risk Outpatient Surgical Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aprepitant 40mg, Placebo.
- Who it may be relevant to
- Registry conditions: Nausea and Vomiting, Postoperative, Prevention. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Drug 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. - Drug 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.
Primary outcome measures
- Rate of complete response according to postoperative nausea and vomitting [Time frame: 48 hours after the surgery]
Secondary outcome measures (6)
- Severity and frequence of nausea and vomiting [Time frame: At discharge from recovery room, usually 1h after the end of the surgery, 24 hours and 48 hours after the surgery]
- Medical economic impact [Time frame: 48 hours after the surgery]
- Quality of recovery [Time frame: Change between baseline (before surgery) and 48 hours after the surgery]
- Incidence of side effects [Time frame: 48 hours after the surgery]
- Patient satisfaction [Time frame: 48 hours after the surgery]
- Analgesic consumptions (Opioid and non opioid) [Time frame: 48 hours after the 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Canada · 1 center
- Centre hospitalier de l'Université de Montréal (CHUM) — Montreal
Identifiers
NCT: NCT07248280 · 2026-13145