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

Information source: Duke University
Information obtained from ClinicalTrials.gov on October 04, 2010
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: Recruiting

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Ashraf S Habib, MBBCH, FRCA, Principal Investigator, Affiliation: Duke University

Overall contact:
Magdi A ElGasim, MD, Phone: 919 681 2217, Email: mike.elgasim@duke.edu

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, Control: Active Control, 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 nausea

Incidence 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.

- 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

Magdi A ElGasim, MD, Phone: 919 681 2217, Email: mike.elgasim@duke.edu

Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Ashraf S Habib, MBBCh, FRCA, Phone: 919-668-6266, Email: habib001@mc.duke.edu
Mike A ElGasim, MD, Phone: 919 681 2217, Email: mike.elgasim@duke.edu
Ashraf S Habib, MBBCh, Principal Investigator
Additional Information

Starting date: September 2007
Last updated: March 30, 2009

Page last updated: October 04, 2010

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