Duke University Medical Center
Durham, North Carolina, 27710, United States
NCT Number: NCT00734929
We hypothesize that the combination of aprepitant with dexamethasone will provide significantly improved prophylaxis against Postoperative nausea and vomiting compared with the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under general anesthesia.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 4
Durham, North Carolina, 27710, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A patient is eligible for inclusion in this study if all of the following criteria apply:
Exclusion criteria
A patient will not be eligible for inclusion in this study if any one or more of the following criteria apply within thirty days of patient enrollment in this clinical trial:
Aprepitant 40 mg + Dexamethasone 10 mg
Ondansetron 4 mg + Dexamethasone 10 mg
Time frame: 48 h
Any vomiting or retching
Time frame: Post operative procedure (OP) hours (0-2, 24, 48)
operative procedure
Time frame: Post OP (0 - 2 hours)
Time frame: 24 h
Any vomiting or retching
Time frame: Post OP (0 - 2 hours)
Time frame: 24 h
Time frame: 48 hour
Time frame: 24 hours Post OP, 48 hours Post OP
complete response rate: defined as no Postoperative nausea and vomiting (PONV) and no need for rescue antiemetics.
Time frame: Post OP hours 0-2, 24 h, 48 h
Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable
Time frame: 48 hours
Time frame: 48 h
Time frame: 48 hour
Participants rated their satisfaction with antiemetic management on a 5 points scale: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)
Duke University
Other
A Comparison of the Combination of Aprepitant and Dexamethasone Versus the Combination of Ondansetron and Dexamethasone for the Prevention of Postoperative Nausea and Vomiting (PONV) in Patients Undergoing Craniotomy
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