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Completed

NCT Number: NCT01020903

Aprepitant for Post-operative Nausea

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.

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Key information

Conditions

Postoperative Nausea Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aprepitant

Procedure

40 mg po pre-op

Other names: Emend

Placebo

Drug

Orally, pre-op

Other names: Sugar pill

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Staten Island University Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 26, 2009
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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