Nausea and Vomiting, Postoperative, Prevention
Conditions
Keywords
Ambulatory care, Aprepitant
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.
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
DRUGAprepitant 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.
DRUGPlacebo
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.
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomized, placebo-controlled, phase III superiority clinical trial conducted in parallel groups with triple blinding
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complete response according to postoperative nausea and vomitting | 48 hours after the surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity and frequence of nausea and vomiting | At discharge from recovery room, usually 1h after the end of the surgery, 24 hours and 48 hours after the surgery | 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 | 48 hours after the surgery | 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 | Change between baseline (before surgery) and 48 hours after the surgery | 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 | 48 hours after the surgery | The potential side effects related to the medication, such as fatigue, dizziness, headaches, abdominal bloating, dyspepsia, hiccups, constipation, or diarrhea will be collected. |
| Patient satisfaction | 48 hours after the surgery | The overall patient satisfaction will be assessed on a visual analog scale from 0 to 10, where 0 represents completally unsatisfied and 10 represents fully satisfied. |
| Analgesic consumptions (Opioid and non opioid) | 48 hours after the surgery | The total opioid consumption will be recorded and expressed in morphine equivalent dose and the consumption of acetaminophen and nonsteroidal anti-inflammatory drugs will also be documented |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORMaxim Roy, MD, FRCPC
Centre hospitalier de l'Université de Montréal (CHUM)
Outcome results
None listed