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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01020903
Other study ID # 09-045
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2009
Est. completion date November 2010

Study information

Verified date November 2023
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Aprepitant
40 mg po pre-op
Drug:
Placebo
Orally, pre-op

Locations

Country Name City State
United States Staten Island University Hospital Staten Island New York

Sponsors (2)

Lead Sponsor Collaborator
Northwell Health Staten Island University Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Diemunsch P, Schoeffler P, Bryssine B, Cheli-Muller LE, Lees J, McQuade BA, Spraggs CF. Antiemetic activity of the NK1 receptor antagonist GR205171 in the treatment of established postoperative nausea and vomiting after major gynaecological surgery. Br J Anaesth. 1999 Feb;82(2):274-6. doi: 10.1093/bja/82.2.274. — View Citation

Outcome

Type Measure Description Time frame Safety issue
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. 1 year
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