Aprepitant vs. Placebo for the Prevention of Postoperative Nausea and Vomiting: a Randomized, Double-blind Study in Patients Undergoing Laparoscopic Cholecystectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwell Health
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Post-operative Nausea and Vomiting
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Laparoscopic cholecystectomy patients.
- •Must be able to swallow a pill.
Exclusion Criteria
- •Liver failure,
- •Age less than
- •Pregnancy, breast-feeding.
- •Pre-op vomiting.
- •Allergy to aprepitant.
- •Need for post-op gastric drainage.
- •Use of drugs that interact with aprepitant.
Arms & Interventions
Aprepitant
Intervention: Aprepitant (Procedure)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Post-operative Nausea and Vomiting
Time Frame: 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 Outcomes
No secondary outcomes reported