Postoperative Nausea
Conditions
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.
Interventions
PROCEDUREAprepitant
40 mg po pre-op
DRUGPlacebo
Orally, pre-op
Sponsors
Staten Island University Hospital
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Laparoscopic cholecystectomy patients. * Must be able to swallow a pill.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aprepitant Aprepitant: 40 mg po pre-op | 0 |
| Placebo Placebo: Orally, pre-op | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Sex/Gender, Customized Male and Female | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Post-operative Nausea and Vomiting
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.
Time frame: 1 year
Population: Records for this study are no longer available as they were destroyed in Hurricane Sandy in 10/2012- we do not have any information to use to update the records. The PI for this study is no longer with the institution and no contact information is available. Since we cannot verify the # of participants analyzed, the numbers were changed to 0.