Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study took place at Duke University Medical Center from September 2007 to June 2009

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Aprepitant	Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
Ondansetron	Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia

Participant Flow:   Overall Study

	Aprepitant	Ondansetron
STARTED	52	55
COMPLETED	51	53
NOT COMPLETED	1	2
prolonged postoperative ventilation	1	2

Reporting Groups

	Description
Aprepitant	Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
Ondansetron	Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia

Baseline Measures

	Aprepitant	Ondansetron	Total
Number of Participants   [units: participants]	52	55	107
Age   [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	52	55	107
>=65 years	0	0	0
Age   [units: years] Mean ± Standard Deviation	51  ± 13	48  ± 13	50  ± 13
Gender   [units: participants]
Female	30	28	58
Male	22	27	49
Region of Enrollment   [units: participants]
United States	52	55	107

1.  Primary:

Cumulative Incidence of Emesis   [ Time Frame: 48 h ]

2.  Secondary:

Incidence of Nausea   [ Time Frame: PACU ]

3.  Secondary:

Incidence of Nausea   [ Time Frame: 24 h ]

4.  Secondary:

Incidence if Nausea   [ Time Frame: 48 h ]

5.  Secondary:

Incidence of Vomiting   [ Time Frame: PACU ]

6.  Secondary:

Incidence of Vomiting   [ Time Frame: 24 h ]

7.  Secondary:

Use of Rescue Antiemetics   [ Time Frame: PACU ]

8.  Secondary:

Use of Rescue Antiemetics   [ Time Frame: 24 h ]

9.  Secondary:

Use of Rescue Antiemetics   [ Time Frame: 48 h ]

10.  Secondary:

Complete Response Rate   [ Time Frame: PACU, 24 h, 48 h ]

11.  Secondary:

Nausea Scores   [ Time Frame: PACU, 24 h, 48 h ]

12.  Secondary:

Number of Vomiting Episodes   [ Time Frame: 48 h ]

13.  Secondary:

Time to First Vomiting   [ Time Frame: 48 h ]

14.  Secondary:

Patient Satisfaction   [ Time Frame: 48 h ]