About this trial
A randomized, double-blind, placebo-controlled, multi-center phase III study to compare the efficacy and safety of aprepitant injection and placebo in the prevention of post-operative nausea and vomiting (PONV).,
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Aprepitant Injection
DrugBefore anesthesia induction, 4.4ml(32mg) was given by a single intravenous injection, which was completed within 30 seconds
Aprepitant Injection Placebo
DrugBefore anesthesia induction, 4.4ml(0mg) was given by a single intravenous injection, which was completed within 30 seconds
Treatment groups
Trial outcomes
Primary outcomes
Complete response (CR) rates over 24 hours after the end of surgery
Complete response (defined as no emetic episodes and no use of rescue therapy)
Secondary outcomes
Proportion of participants who have no nausea in the 0 to 24 hours following the end of surgery
No nausea(defined as a visual analogue scale (VAS) nausea score \< 1.)
Proportion of participants who have significant nausea in the 0 to 24 hours following the end of surgery
Significant nausea(defined as a visual analogue scale (VAS) nausea score≥4)
Proportion of participants who have no vomiting or retching in the 0 to 24 hours following the end of surgery
No vomiting or retching(Defined as whether or not use remedy treatment had no vomiting)
Proportion of participants who use the remedial treatment in the 0 to 24 hours following the end of surgery
Other outcomes
Number of participants with treatment-related adverse events as assessed by NIH
Safety was assessed by Adverse events (AEs) were recorded after administration.
Locations
Sponsors and contacts
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