Comparison of Adding EMEND to PONV/PDNV Treatment Regimen

Study Overview
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Brief Summary
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This study is looking at whether the addition of Aprepitant (Emend), an antiemetic, will provide added efficacy if added to 2 drugs that are already used as a standard of care for post-operative nausea and vomiting and post-discharge nausea and vomiting.

Detailed Description
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This study is looking at whether the addition of a fairly new drug for the treatment of post-operative nausea and vomiting (PONV) and post-discharge nausea and vomiting (PDNV) will provide added efficacy if added to 2 drugs that are already used as a standard of care for PONV and PDNV. The patients that will be looked at will be deemed at higher risk for PONV and PDNV based on the procedure they are having done and/or on patient risk factors.

Official Title
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A Comparison Study to Determine the Increased Efficacy of Adding EMEND to the Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: aprepitant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with at least 2 of the common risk factors for PONV/PDNV; patients having a procedure deemed at high risk for PONV/PDNV Exclusion Criteria: patients under 19 years of age; pregnant and breast-feeding patients

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EMEND Added to the Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting<br>The addition of Aprepitant (Emend), an antiemetic, to 2 drugs that are already used as a standard of care for post-operative nausea and vomiting and post-discharge nausea and vomiting. | Drug: aprepitant<br>* Emend 40mg by mouth 30 minutes before procedure x 1<br>* Other names: EMEND;|
| No Intervention: Standard Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting<br>No addition of Aprepitant (Emend), an antiemetic, to 2 drugs that are already used as a standard of care for post-operative nausea and vomiting and post-discharge nausea and vomiting. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EMEND Added to Standard Treatment of Post-operative and Post-Discharge Nausea and Vomiting | To see if by adding EMEND to a standard treatment regimen for PONV/PDNV, added efficacy will be obtained. To see if there is more efficacy for PONV vs. PDNV by adding EMEND to the treatment regimen | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nausea and Vomiting