CompletedPhase 4

Aprepitant for PONV Prophylaxis in Outpatient Plastic Surgery

United States150 participantsStarted 2008-06

Plain-language summary

Hypothesis: Aprepitant plus ondansetron is more effective than ondansetron plus placebo for prevention of postoperative emesis in patients at moderate-to-high risk for PONV for up to 48 hours after surgery. Specific Aim: To determine the incidence of PONV during the first 48 hours after surgery; in patients who have received aprepitant plus ondansetron versus ondansetron plus placebo for up to 48 hours after surgery.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent * ASA (American Society of Anesthesiologists physical status) 1-3 * Male and female Age 18 to 65 years * Plastic surgical procedure (Breast, Face, Liposuction, etc., and excluding peripheral procedures such as hand surgery and limited-scope split-thickness skin grafts) of at least 1 hour in duration * General anesthesia * Presence of 2 (men)/3 (women) or more risk factors for PONV * Ambulatory surgery with same-day discharge planned Exclusion Criteria: * Patient refusal * Patients who have received other antiemetics prior to their procedure * History of allergy or sensitivity to study drugs * Pregnancy - Patients are asked date of last menstrual period, use of birth control, tubal ligation, if they have had unprotected sexual intercourse and if they think if there is any possibility of being pregnant, and when appropriate, a pregnancy test will be obtained which is the standard of care at Magee-Womens Hospital. * Patients with a history of chronic opioid use (chronic pain syndrome) as these patients will be less likely to have PONV

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Having Post-operative Emesis and Nausea.

Timeframe: 48 hours post surgery

Trial details

NCT IDNCT00659945

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-11

Results submitted2011-08-10

View on ClinicalTrials.gov More Postoperative Nausea and Vomiting trials