Aprepitant for Postoperative Nausea and Vomiting
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if adding a medicine called aprepitant can reduce nausea and vomiting after outpatient surgery. It focuses on patients likely to experience these symptoms, especially those with a history of such issues, non-smokers, females, or those using pain medication post-surgery. Participants will receive either aprepitant or a placebo (a pill that resembles the medicine but isn't) alongside their usual anti-nausea treatment. This study targets individuals aged 18 or older who have experienced nausea after surgery or motion, such as in cars or boats. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
You may need to stop taking certain medications that interact with aprepitant, such as pimozide, terfenadine, astemizole, comtadin, or cisapride. It's best to discuss your current medications with the trial team to see if any changes are needed.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that aprepitant is generally safe for people. Studies have found that aprepitant, which blocks certain signals in the brain, effectively prevents nausea and vomiting after surgery, even when other treatments fail. Importantly, these studies also found that patients tolerate aprepitant well.
No major safety concerns have been reported with using aprepitant for this purpose. Its use in other conditions has further clarified its safety profile. In summary, evidence suggests aprepitant is a safe option for preventing nausea and vomiting after surgery.12345Why do researchers think this study treatment might be promising?
Aprepitant is unique because it offers a novel approach to tackling postoperative nausea and vomiting (PONV) by blocking neurokinin-1 (NK1) receptors, which are involved in the vomiting reflex. This is different from standard treatments like ondansetron or dexamethasone that primarily target serotonin or corticosteroid pathways. Researchers are excited about aprepitant because it can potentially enhance the overall effectiveness of antiemetic therapy, possibly providing longer-lasting relief and reducing the incidence of nausea and vomiting after surgery.
What evidence suggests that aprepitant might be an effective treatment for postoperative nausea and vomiting?
In this trial, participants will receive either aprepitant or a placebo. Research has shown that aprepitant effectively reduces nausea and vomiting after surgery. Specifically, studies indicate it significantly lowers the chance of vomiting in the first 24 hours post-surgery, with a risk ratio of 0.26, highlighting its effectiveness. It also aids with delayed eating and movement after surgery. Most studies found that aprepitant works well, partly due to its longer duration of action. Adding aprepitant could improve outcomes for those at high risk of nausea and vomiting after outpatient surgery.14567
Who Is on the Research Team?
Maxim Roy, MD, FRCPC
Principal Investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Are You a Good Fit for This Trial?
This trial is for high-risk patients experiencing nausea and vomiting after outpatient surgery, despite following American Society of Anesthesiologists' recommendations. Specific eligibility criteria are not provided, but typically include adults who've had certain types of surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a 40 mg capsule of aprepitant or placebo in addition to standard antiemetic prophylaxis
Postoperative Monitoring
Participants are monitored for postoperative nausea and vomiting, and other outcomes for 48 hours after surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Aprepitant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor