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.
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).
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).
Parallel
Aprepitant 40mg
DrugJust 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.
Placebo
DrugJust before the patient is taken to the operating room, a single oral capsule of 40 mg of placebo will be given to the participant.
Rate of complete response according to postoperative nausea and vomitting
The rate of 'complete response' (CR), defined as the proportion of patients who experienced no episodes of postoperative nausea or vomiting (PONV) and did not require rescue medication following the addition of 40mg of aprepitant to a multimodal prevention strategy for PONV in high-risk patients during the first 48 hours following surgery.
Severity and frequence of nausea and vomiting
The severity of nausea will be assessed using a questionnaire called the Simplified Postoperative Nausea and Vomitting Severity Score (SPONVSS) which indicates the number of episodes of vomiting and regurgitations from 0 to 4, where 0 represents none, 1, 2 and 3 are the number of episodes and 4 being 4 episodes or more, at three different time points (upon discharge from the recovery room, at 24 and 48 hours after surgery).
Medical economic impact
The medical economic impact will be evaluated in terms of cost-effectiveness by analyzing the hospital admission conversions from ambulatory to inpatient admission, calls to 811 for health advice or the CHUM Patient Health Line, returns to the emergency room, and unplanned medical consultations for reasons exclusively related to PONV. A Willingness to pay questionnaire with one hypothetical question will also be asked 48 hours after surgery.
Quality of recovery
QoR15 is a valid questionnaire to measure the quality of recovery after surgery and anaesthesia, which includes 15 questions. Each of the 15 items are scored by the patient from 0 (worst score) to 10 (optimal score), giving a lowest possible score of 0 (worst outcome), and a highest possible score of 150 (optimal outcome).
Incidence of side effects
The potential side effects related to the medication, such as fatigue, dizziness, headaches, abdominal bloating, dyspepsia, hiccups, constipation, or diarrhea will be collected.
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