Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Nausea and Vomiting
Intervention: Aprepitant + Dexamethasone (Drug); Ondansetron + Dexamethasone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Duke University Official(s) and/or principal investigator(s): Ashraf S Habib, MBBCH, FRCA, Principal Investigator, Affiliation: Duke University
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 ondansetron and dexamethasone, in patients undergoing craniotomy under
general anesthesia.
Clinical Details
Official title: A Comparison of the Combination of Aprepitant and Dexamethasone Versus the Combination of Ondansetron and Dexamethasone for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Craniotomy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Cumulative Incidence of Emesis
Secondary outcome: Incidence of NauseaIncidence of Nausea Incidence if Nausea Incidence of Vomiting Incidence of Vomiting Use of Rescue Antiemetics Use of Rescue Antiemetics Use of Rescue Antiemetics Complete Response Rate Nausea Scores Number of Vomiting Episodes Time to First Vomiting Patient Satisfaction
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Duke University Medical Center, Durham, North Carolina 27710, United States
Additional Information
Starting date: September 2007
Last updated: May 21, 2013
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