Aprepitant for Nausea and Vomiting
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if the medication aprepitant can reduce nausea and vomiting after ear surgery. Participants will receive either aprepitant or a placebo (a pill with no active medicine) before their surgery to assess which is more effective. This trial is ideal for adults scheduled for specific ear surgeries, such as tympanoplasty or stapedectomy. Those relying on hormonal birth control should note that aprepitant might reduce its effectiveness, so additional contraception is recommended for a month after surgery. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.
Will I have to stop taking my current medications?
If you are taking medications that affect certain liver enzymes (CYP3A4 or CYP2CP), you may need to stop them because they could interact with the study medication. It's best to discuss your current medications with the study team to see if any changes are needed.
What is the safety track record for this treatment?
Research has shown that aprepitant is generally safe for use. Studies have demonstrated its effectiveness in reducing nausea and vomiting, particularly in cancer patients undergoing chemotherapy. For example, one study found that aprepitant controlled vomiting in 83.33% of patients, compared to only 45.83% of those who did not take the drug. This suggests that aprepitant is both effective and well-tolerated.
Regarding safety, another study examined how adult patients with chemotherapy-related nausea responded to aprepitant. The study confirmed that patients tolerated it well, with no major side effects reported.
Overall, the use of aprepitant in various medical conditions and its positive results in clinical studies suggest it is a safe option for managing nausea and vomiting.12345Why are researchers enthusiastic about this study treatment?
Aprepitant is unique because it targets the neurokinin-1 (NK1) receptor, which plays a key role in the body's nausea and vomiting pathway. Unlike standard treatments like ondansetron or metoclopramide, which primarily target serotonin receptors, aprepitant offers a different mechanism of action. This makes it particularly exciting for researchers, as it could provide relief for patients who do not respond well to existing medications, potentially offering a new option for managing nausea and vomiting.
What evidence suggests that aprepitant might be an effective treatment for nausea and vomiting after ear surgery?
Research has shown that aprepitant helps reduce nausea and vomiting. In this trial, participants in the treatment arm will receive 80 mg of aprepitant. Previous studies have demonstrated that this dosage significantly reduces vomiting after surgery more than it reduces nausea. Another study found it very effective in preventing nausea and vomiting caused by chemotherapy. Aprepitant also reduces the need for additional anti-nausea medications and improves overall treatment success. This medication has proven effective and is already used to prevent these symptoms in other situations.26789
Are You a Good Fit for This Trial?
This clinical trial is for individuals undergoing ear surgery who are at risk of post-operative nausea and vomiting. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative
Participants receive oral aprepitant 80mg or placebo within an hour of induction
Post-operative Monitoring
Participants are monitored for incidence of nausea and vomiting using the Postoperative Nausea and Vomiting Intensity Scale
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Aprepitant
Trial Overview
The trial is testing Aprepitant, a medication intended to reduce nausea and vomiting after ear surgery, against a placebo (a substance with no therapeutic effect). Participants will be randomly assigned to receive either Aprepitant or the placebo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Oral aprepitant 80mg within an hour of induction
Placebo capsule within an hour of induction
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sir Mortimer B. Davis - Jewish General Hospital
Lead Sponsor
Citations
Efficacy and safety of Aprepitant-containing triple therapy ...
Conclusions: Aprepitant-containing triple therapy is highly effective in the prevention and treatment of CINV, with reliable medication safety.
Effect of Aprepitant for the Prevention of Chemotherapy ...
Adding aprepitant to palonosetron and dexamethasone was effective in reducing nausea and vomiting for women who received moderately emetogenic chemotherapy.
3.
journals.lww.com
journals.lww.com/md-journal/fulltext/2023/07210/the_efficacy_of_aprepitant_for_the_prevention_of.42.aspxThe efficacy of aprepitant for the prevention of... : Medicine
Findings showed that administration of 80 mg aprepitant reduced postoperative vomiting significantly more than postoperative nausea (OR: 8.6; 95 ...
The efficacy of aprepitant for the prevention ...
Further, administration of 80 mg aprepitant was better at preventing vomiting than nausea (OR: 8.6; 95% CI: 3.84, 19. 29; P < .00001). No ...
Aprepitant and fosaprepitant as a prophylactic antiemetic ...
Aprepitant reduces the incidence of postoperative nausea, vomiting and the use of rescue antiemetics and increases the complete response rate among adult ...
Aprepitant - StatPearls - NCBI Bookshelf - NIH
Aprepitant and fosaprepitant are drugs used to prevent nausea and vomiting in cancer patients. Aprepitant can be taken orally or intravenously ( ...
A study on the efficacy and safety of aprepitant injection ...
The effective control rate of acute-phase vomiting in the treatment group was 83.33%, significantly higher than 45.83% in the control group, ...
The Efficacy of Aprepitant
A randomized, double-blind comparison of the NK1 antagonist, aprepitant, versus ondansetron for the prevention of postoperative nausea and vomiting.
Assessment of efficacy, safety, and tolerability of aprepitant ...
The present study was undertaken to assess efficacy, safety, and tolerability of Aprepitant in adult patients with chemotherapy induced nausea ...
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