Expired Study
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Durham, North Carolina 27710


Purpose:

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.


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.


Study is Available At:


Original ID:

1404


NCT ID:

NCT00734929


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Duke University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

110


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Ashraf S Habib, MBBCH, FRCA
Principal Investigator
Duke University

Study Dates

Start Date:September 2007
Completion Date:June 2009
Completion Type:Actual
Primary Completion Date:June 2009
Primary Completion Type:Actual
Verification Date:October 2010
Last Changed Date:October 6, 2010
First Received Date:August 13, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Patient satisfaction
Time Frame:48 h
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to first vomiting
Time Frame:48 h
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:number of vomiting episodes
Time Frame:48 h
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Nausea scores
Time Frame:PACU, 24 h, 48 h
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Complete response rate
Time Frame:PACU, 24 h, 48 h
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Use of rescue antiemetics
Time Frame:48 h
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Use of rescue antiemetics
Time Frame:24 h
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Use of rescue antiemetics
Time Frame:PACU
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of vomiting
Time Frame:24 h
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of vomiting
Time Frame:PACU
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence if nausea
Time Frame:48 h
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of nausea
Time Frame:24 h
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of nausea
Time Frame:PACU
Safety Issues:False
Outcome Type:Primary Outcome
Measure:cumulative incidence of emesis
Time Frame:48 h
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Aprepitant + Dexamethasone
Description:Aprepitant 40 mg + Dexamethasone 10 mg
Arm Name:1
Intervention Type:Drug
Name:Ondansetron + Dexamethasone
Description:Ondansetron 4 mg + Dexamethasone 10 mg
Arm Name:2

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description:Ondansetron + Dexamethasone
Study Arm Type:Experimental
Arm Name:1
Description:Aprepitant + dexamethasone

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Duke University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Merck

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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