Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy
1 other identifier
interventional
150
1 country
1
Brief Summary
- Gynecological surgery is associated with a high incidence of postoperative nausea and vomiting.
- NK1 receptor antagonists such as aprepitant appear to be highly effective for treating acute and delayed emesis, and yet understanding of the efficacy of different doses of aprepitant is limited.
- We performed a prospective, randomized, double-blinded placebo-controlled study of 123 female adults scheduled for laparoscopic hysterectomy who received 80 mg aprepitant, 125 mg aprepitant, or a placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 20, 2011
CompletedFirst Posted
Study publicly available on registry
September 26, 2011
CompletedSeptember 26, 2011
September 1, 2011
6 months
September 20, 2011
September 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The numbers (and percentages) of patients who experienced complete response
* The numbers (and percentages) of patients who experienced complete response, i.e. no nausea, retching, vomiting, or need for rescue treatment * required rescue therapy and peak nausea scores * Adverse effects in the three treatment groups
48 hours postoperatively
Study Arms (2)
aprepitant 125mg
ACTIVE COMPARATORNK1 receptor antagonist
Aprepitant 80 mg
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- female laparoscopic hysterectomy isoflurane anesthesia postoperative opioid use
You may not qualify if:
- liver disease neurologic disease active pulmonary disease cardiac arrhythmia allergies to any perioperative medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gachon University Gil Medical Centerlead
- Asan Medical Centercollaborator
- University of California, San Franciscocollaborator
Study Sites (1)
Gil Medical Center Gachon University
Inchon, 405-760, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
WOL SEON JUNG, M.D. Ph.D.
Gil Medical Center Gachon University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
September 20, 2011
First Posted
September 26, 2011
Study Start
March 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
September 26, 2011
Record last verified: 2011-09