Oral Aprepitant and Lower Dose Dexamethasone Versus Aprepitant Alone for Preventing Postoperative Nausea and Vomiting (PONV) After Elective Laparoscopic Surgeries
A Randomized, Double-Blind Comparison of Oral Aprepitant and Lower Dose Dexamethasone vs Aprepitant Alone for Preventing Postoperative Nausea and Vomiting After Elective Laparoscopic Surgeries
2 other identifiers
interventional
50
1 country
1
Brief Summary
The combination of aprepitant and lower dose dexamethasone is superior to aprepitant alone with respect to the proportion of patients with a complete response (no vomiting and no use of rescue therapy) during 24 hours after the placement of last suture/staple.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 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
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 3, 2009
CompletedFirst Posted
Study publicly available on registry
February 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedFebruary 4, 2009
February 1, 2009
10 months
February 3, 2009
February 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the incidences of nausea, vomiting, need for rescue medication
1 hour, 2 hours, 24 hours after surgery
Secondary Outcomes (1)
incidences of unplanned hospital admission; duration of PACU stay
24 hours
Study Arms (2)
Active Comparator
ACTIVE COMPARATORPatients receive aprepitant and dexamethasone for prevention of postoperative nausea and vomiting
Placebo Comparator
PLACEBO COMPARATORPatients receiving aprepitant and placebo dexamethasone for prevention of postoperative nausea and vomiting
Interventions
Dexamethasone 5 mg administered intravenously following endotracheal intubation
Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
Eligibility Criteria
You may qualify if:
- at least 18 years old
- ASA physical status I-III
- must have at least 2 risk factors for PONV
You may not qualify if:
- pregnant or breast feeding patients
- antiemetic medication in previous 24 hours
- allergy or other contraindication to study medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Main Line Healthlead
- Merck Sharp & Dohme LLCcollaborator
- Drexel University College of Medicinecollaborator
Study Sites (1)
Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dmitri Chamchad, MD
Lankenau Hospital, Lankenau Institute for Medical Research
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 3, 2009
First Posted
February 4, 2009
Study Start
February 1, 2009
Primary Completion
December 1, 2009
Last Updated
February 4, 2009
Record last verified: 2009-02