- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01020903
Aprepitant for Post-operative Nausea
November 17, 2023 updated by: Northwell Health
Aprepitant vs. Placebo for the Prevention of Postoperative Nausea and Vomiting: a Randomized, Double-blind Study in Patients Undergoing Laparoscopic Cholecystectomy
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Staten Island, New York, United States, 10305
- Staten Island University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Orally, pre-op
Other Names:
|
Active Comparator: Aprepitant
|
40 mg po pre-op
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael B Silverberg, MD, Staten Island University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
November 24, 2009
First Submitted That Met QC Criteria
November 25, 2009
First Posted (Estimated)
November 26, 2009
Study Record Updates
Last Update Posted (Estimated)
November 22, 2023
Last Update Submitted That Met QC Criteria
November 17, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Signs and Symptoms, Digestive
- Vomiting
- Nausea
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Neurokinin-1 Receptor Antagonists
- Aprepitant
Other Study ID Numbers
- 09-045
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Nausea
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Cukurova UniversityTarsus UniversityRecruitingNausea, Postoperative | Vomiting, Postoperative | APFEL RİSK SCORETurkey
-
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Lancaster General HospitalCompletedBariatric Surgery Candidate | Nausea, PostoperativeUnited States
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Northwell HealthTerminatedPostoperative Pain | Postoperative Nausea | Postoperative VomitingUnited States
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Hôpital Privé de Parly II - Le ChesnayCompletedPostoperative Nausea | Postoperative Vomiting | Postoperative EmesisFrance
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Yeungnam University College of MedicineCompletedPostoperative Nausea | Postoperative VomitingKorea, Republic of
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Sevgi GürCompletedPostoperative Nausea and VomitingTurkey
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Khon Kaen UniversityCompleted
Clinical Trials on Aprepitant
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The Hospital for Sick ChildrenCompletedChemotherapy-induced Nausea and VomitingCanada
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University Hospital, RouenCompleted
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Duke UniversityMerck Sharp & Dohme LLCCompleted
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University Hospital Inselspital, BerneRecruitingPostoperative Nausea and Vomiting | Bariatric SurgerySwitzerland