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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
115
Aprepitant 40 mg + Dexamethasone 10 mg
Ondansetron 4 mg + Dexamethasone 10 mg
Duke University Medical Center
Durham, North Carolina, United States
Cumulative Incidence of Emesis
Any vomiting or retching
Time frame: 48 h
Incidence of Nausea
operative procedure
Time frame: Post operative procedure (OP) hours (0-2, 24, 48)
Incidence of Vomiting (Post OP)
Time frame: Post OP (0 - 2 hours)
Incidence of Vomiting (24 Hours)
Any vomiting or retching
Time frame: 24 h
Use of Rescue Antiemetics (Post OP)
Time frame: Post OP (0 - 2 hours)
Use of Rescue Antiemetics (24 Hours)
Time frame: 24 h
Use of Rescue Antiemetics (48 Hours)
Time frame: 48 hour
Number of Participants With a Complete Response Rate
complete response rate: defined as no Postoperative nausea and vomiting (PONV) and no need for rescue antiemetics.
Time frame: 24 hours Post OP, 48 hours Post OP
Average Nausea Score
Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable
Time frame: Post OP hours 0-2, 24 h, 48 h
Number of Vomiting Episodes
Time frame: 48 hours
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Time to First Vomiting
Time frame: 48 h
Number of Participants Who Rated Their Satisfaction With Antiemetic Management as "Very Satisfied"
Participants rated their satisfaction with antiemetic management on a 5 points scale: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)
Time frame: 48 hour