Aprepitant for Post-operative Nausea

N/ACompletedNCT01020903

Northwell Health200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

200

Conditions

Postoperative Nausea

Interventions

AprepitantPROCEDURE

40 mg po pre-op

PlaceboDRUG

Orally, pre-op

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Staten Island University Hospital

Staten Island, New York, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.