Aprepitant for Post-operative Nausea
- Conditions
- Postoperative Nausea
- Interventions
- Drug: PlaceboProcedure: Aprepitant
- Registration Number
- NCT01020903
- Lead Sponsor
- Northwell Health
- Brief Summary
Anesthesia, especially for laparoscopic surgery, can cause post-operative nausea and vomiting. Most patients are given two drugs, decadron and ondansetron, to try to minimize this. This study is to determine if a new drug, aprepitant, would add any benefit in terms of post-op nausea prevention. All laparoscopic cholecystectomy study patients will receive decadron and ondansetron. Half the patients will receive aprepitant in addition. The other half will receive placebo. The study will be randomized and double-blind.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Laparoscopic cholecystectomy patients.
- Must be able to swallow a pill.
- Liver failure,
- Age less than 18.
- Pregnancy, breast-feeding.
- Pre-op vomiting.
- Allergy to aprepitant.
- Need for post-op gastric drainage.
- Use of drugs that interact with aprepitant.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Aprepitant Aprepitant -
- Primary Outcome Measures
Name Time Method Post-operative Nausea and Vomiting 1 year Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records. In addition, the PI for this study is no longer with the institution and no contact information is available.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Staten Island University Hospital
🇺🇸Staten Island, New York, United States