Study Stopped
Slow accrual.
Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy
Prevention of Postoperative Nausea and Vomiting in a Gynecologic Surgery Population: A Randomized Placebo Controlled Trial of Aprepitant NK-1-receptor Antagonist
1 other identifier
interventional
256
1 country
1
Brief Summary
The purpose of the study is to determine whether 40 mg aprepitant administered before surgery is effective for preventing vomiting in the first 24 hours after surgery in women undergoing elective hysterectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 24, 2009
CompletedFirst Posted
Study publicly available on registry
April 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
March 30, 2012
CompletedMarch 30, 2012
March 1, 2012
4.3 years
April 24, 2009
February 1, 2012
March 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Emesis
This is the number of participants who had an episode of vomiting within 24 hours after emergence from anesthesia.
24 hours after emergence from anesthesia
Study Arms (2)
Aprepitant
EXPERIMENTAL40 mg aprepitant
Placebo
PLACEBO COMPARATORPlacebo
Interventions
40 mg administered orally with a sip of water prior to anesthesia induction.
Eligibility Criteria
You may qualify if:
- Scheduled for elective hysterectomy at Mayo Clinic in Arizona
- ASA I, II, or III
You may not qualify if:
- Pregnancy
- Concomitant bowel surgery other than appendectomy
- Hypersensitivity to study drug or rescue medication
- Preoperative score for nausea greater than 4 out of 10 points
- Severe hepatic insufficiency (Child-Pugh score \> 9)
- Any condition which impairs the patient's ability to complete study assessments
- Intraoperative hemodynamic instability
- ICU admission
- Prolonged postoperative intubation
- Rifampin, carbamazepine, phenytoin, or other drugs which strongly induce CYP3A4 activity
- Other antiemetic within 12 hours prior to surgery
- Participation in a clinical trial using an investigational product
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Phoenix, Arizona, 85054, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Results might have been influenced by selection bias.
Results Point of Contact
- Title
- Javier Magrina MD
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Javier Magrina, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 24, 2009
First Posted
April 27, 2009
Study Start
July 1, 2007
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
March 30, 2012
Results First Posted
March 30, 2012
Record last verified: 2012-03