Combination Antiemetic Regimen for Prevention of PONV in Breast Surgery Patients

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to compare the efficacy of the use of oral aprepitant in combination with intravenous ondansetron and dexamethasone with the efficacy provided by the use of oral aprepitant and dexamethasone for preventing vomiting during the first 24-48 hours after breast surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Scott and White Hospital & Clinic
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Antiemetics; Aprepitant; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant; Ondansetron

Criteria

Inclusion Criteria:

All of the following criteria must be met for the potential subject to be eligible for participation:

1. The subject is a female scheduled to undergo ambulatory breast surgery performed under general anesthesia

2. The subject is expected to undergo general inhalation anesthesia.

3. The subject presents with two of the three following high-risk factors associated with PONV (must be in their medical history in order to be eligible)

• She is a non-smoker.

• She has documented history of PONV and/or motion sickness.

• She is expected to receive intra-operative and postoperative opioid.

4. The subject's American Society of Anesthesiologist physical status is ASA I-III

5. The subject is between18 to 65 years of age.

6. The subject is expected to be discharged from the hospital/surgical center on the same day as the surgery.

7. The subject has provided written informed consent to participate in the study.

If any of the following exclusion criteria are met, the potential subject is NOT eligible for participation:

1. The subject has a history of allergic reaction to, intolerances of or contraindications for any of the study medications or required anesthetic agents.

2. The subject has received or is expected to receive any excluded preoperative drug within 48 hours prior to induction; or is expected to receive any excluded intra-operative or postoperative medications.

3. The subject is pregnant or lactating. (If the potential subject is pre-menopausal, a urine pregnancy test must be performed within 24 hours/1 day of study prior to the planned surgery time and confirmed negative in order for the potential subject to be enrolled).

4. The subject is taking warfarin.

5. The subject has a history of alcohol and/or drug abuse within 1 year of study medication, or has a positive screening or pre-study test for alcohol or drugs of abuse.

6. The subject is expected to require the use of a nasogastric tube postoperatively.

7. The subject has a diagnosed latex allergy.

8. The subject has used oral aprepitant (Emend®) within the last 30 days.

9. The subject has participated in a randomized study or has been exposed to any experimental drug within 30 days prior to enrollment of this study.

Exclusion Criteria: