Aprepitant for PONV Prophylaxis in Outpatient Plastic Surgery

This study has been completed.

Study NCT00659945 Information provided by University of Pittsburgh

First Received on April 15, 2008. Last Updated on November 2, 2011 History of Changes

Results First Received: August 10, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver); Primary Purpose: Prevention
Condition:	Postoperative Nausea and Vomiting
Interventions:	Drug: Aprepitant plus Ondansetron Drug: Ondansetron plus placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Prospective, double blinded, randomized, two arm evaluation of 150 subjects at high risk for PONV undergoing a standardized general anesthetic with ondansetron and either aprepitant or a placebo. Recruitment period was from June 2008 through November 2009 in the preoperative holding area prior to surgery.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Men and women between 18 and 65 years, at high risk for PONV, undergoing ambulatory plastic surgery under general anesthesia. Exclusion criteria included patient refusal, given other anti-emetics prior to their procedure, history of allergy or sensitivity to study drugs, pregnancy, chronic opioid use, and surgery under intravenous (iv) sedation.

Reporting Groups

	Description
Group A(Oral Aprepitant+iv Ondansetron)	oral aprepitant 40 mg plus intravenous ondansetron 4 mg
Group B(Oral Placebo+iv Ondansetron)	oral placebo plus intravenous ondansetron 4 mg IV

Participant Flow: Overall Study

	Group A(Oral Aprepitant+iv Ondansetron)	Group B(Oral Placebo+iv Ondansetron)
STARTED	75	75
COMPLETED	75	75
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Group A(Oral Aprepitant+iv Ondansetron)	oral aprepitant 40 mg plus intravenous ondansetron 4 mg
Group B(Oral Placebo+iv Ondansetron)	oral placebo plus intravenous ondansetron 4 mg IV

Baseline Measures

	Group A(Oral Aprepitant+iv Ondansetron)	Group B(Oral Placebo+iv Ondansetron)	Total
Number of Participants [units: participants]	75	75	150
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	75	75	150
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	43.7 ± 14.3	45.3 ± 16.3	44.5 ± 15.3
Gender [units: participants]
Female	70	70	140
Male	5	5	10
Region of Enrollment [units: participants]
United States	75	75	150
Emesis ^[1] [units: participants]	75	75	150

[1]	Emesis = the reflex action of ejecting stomach contents through the mouth (definition from Bantam Medical Dictionary). The condition was patients with 2 or more major risk factors were eligible for the study. Major PONV patient-related risk factors for inclusion into the study were 1) female gender 2) history of PONV or history of motion sickness 3) non-smoking status, and 4) postoperative use of opioids.

[1]

Emesis = the reflex action of ejecting stomach contents through the mouth (definition from Bantam Medical Dictionary). The condition was patients with 2 or more major risk factors were eligible for the study. Major PONV patient-related risk factors for inclusion into the study were 1) female gender 2) history of PONV or history of motion sickness 3) non-smoking status, and 4) postoperative use of opioids.

Outcome Measures

1. Primary:

Number of Participants Having Post-operative Emesis and Nausea. [ Time Frame: 48 hours post surgery ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Manuel C. Vallejo, MD
Organization: University of Pittsburgh
phone: 412-641-4260
e-mail: vallejomc@anes.upmc.edu

No publications provided

Responsible Party:	Manuel C. Vallejo, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00659945 History of Changes
Other Study ID Numbers:	PRO07070325
Study First Received:	April 15, 2008
Results First Received:	August 10, 2011
Last Updated:	November 2, 2011
Health Authority:	United States: Institutional Review Board