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Clinical trial

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

ID
Name
09-045
Description
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.
Trial arms
Trial start
2009-11-01
Estimated PCD
2010-11-01
Trial end
2010-11-01
Status
Completed
Treatment
Aprepitant
40 mg po pre-op
Arms:
Aprepitant
Other names:
Emend
Placebo
Orally, pre-op
Arms:
Placebo
Other names:
Sugar pill
Size
200
Primary endpoint
Post-operative Nausea and Vomiting
1 year
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 200, 'type': 'ACTUAL'}}
Updated at
2023-11-22

1 organization

1 product

1 indication

Organization
Northwell Health
Product
Placebo
Indication
postoperative nausea