Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:September 2007
End Date:June 2009

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A Comparison of the Combination of Aprepitant and Dexamethasone Versus the Combination of Ondansetron and Dexamethasone for the Prevention of Postoperative Nausea and Vomiting (PONV) in Patients Undergoing Craniotomy

We hypothesize that the combination of aprepitant with dexamethasone will provide
significantly improved prophylaxis against Postoperative nausea and vomiting compared with
the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under
general anesthesia.


Inclusion Criteria:

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 Criteria:

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.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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