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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia

Group Type EXPERIMENTAL

Aprepitant + Dexamethasone

Intervention Type DRUG

Aprepitant 40 mg + Dexamethasone 10 mg

2

Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia

Group Type ACTIVE_COMPARATOR

Ondansetron + Dexamethasone

Intervention Type DRUG

Ondansetron 4 mg + Dexamethasone 10 mg

Interventions

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Aprepitant + Dexamethasone

Aprepitant 40 mg + Dexamethasone 10 mg

Intervention Type DRUG

Ondansetron + Dexamethasone

Ondansetron 4 mg + Dexamethasone 10 mg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No