Aprepitant for Post-operative Nausea

Postoperative Nausea Clinical Trial

Official title:

Aprepitant vs. Placebo for the Prevention of Postoperative Nausea and Vomiting: a Randomized, Double-blind Study in Patients Undergoing Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020903
• Other study ID #: 09-045
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea
• Postoperative Nausea and Vomiting

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