Status:
COMPLETED
Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy
Lead Sponsor:
Duke University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Postoperative Nausea and Vomiting
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
We hypothesize that the combination of aprepitant with dexamethasone will provide significantly improved prophylaxis against Postoperative nausea and vomiting compared with the combination of ondanset...
Eligibility Criteria
Inclusion
- A patient is eligible for inclusion in this study if all of the following criteria apply:
- Age: 18-75 years of age
- Surgery: craniotomy under general anesthesia.
- American Society of Anesthesiologists (ASA) Status: ASA: I, II, or III
- Language: Fluent in the English language
- Informed Consent: Written informed consent must be obtained.
Exclusion
- A patient will not be eligible for inclusion in this study if any one or more of the following criteria apply within thirty days of patient enrollment in this clinical trial:
- Medical: Any condition that may impair a patient's ability to complete any of the study assessments or confound interpretation of results.
- Hypersensitivity: Patient has a known immediate or delayed hypersensitivity reaction or known idiosyncrasy to any of the two study medications, ondansetron, or aprepitant.
- Other Drugs: Patients should not be taking medications with known antiemetic properties (phenothiazines, butyrophenones, antihistamines), nor should they receive metoclopramide, or other antiemetics preoperatively or 12 hours before the scheduled surgical procedure.
- Pregnant or lactating females: A pregnancy test will be performed within 24 hours of entering the study for females of childbearing potential.
- Substance Abuse: Clinically significant abuse of substances (alcohol, illicit or prescribed medications) such that the patient is unable to provide informed consent or reliably complete any of the study assessments.
- Psychiatric Disease: History of a psychiatric illness that may impair the patient's ability to provide informed consent or complete any of the study assessments.
- Nausea verbal rating score (VRS): A VRS nausea score \> 3 (scale 0-10) in the preoperative holding area before pretreatment with the study medications.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00734929
Start Date
September 1 2007
End Date
June 1 2009
Last Update
March 13 2017
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710