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).,
In this study, a randomized, double-blind, placebo-controlled multicenter study will be conducted to evaluate the efficacy and safety of aprepitant injection in the prevention of post-operative nausea and vomiting (PONV).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
486
Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds
Before anesthesia induction, 4.4ml(0mg） was given by a single intravenous injection, which was completed within 30 seconds
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)
Time frame: 0-24 hours after the end of surgery
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.）
Time frame: 0-24 hours after the end of surgery
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）
Time frame: 0-24 hours after the end of surgery
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）
Time frame: 0-24 hours after the end of surgery
Proportion of participants who use the remedial treatment in the 0 to 24 hours following the end of surgery
Time frame: 0-24 hours after the end of surgery
Time to treatment failure in the 0 to 24 hours following the end of surgery
defined as the time to the first episode of vomiting (vomiting or retching) or the time to rescue therapy, whichever occurred first.
Time frame: 0-24 hours after the end of surgery
Proportion of participants who have no vomiting or retching in the 0 to 48 hours following the end of surgery
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No vomiting or retching（Defined as whether or not use remedy treatment had no vomiting）
Time frame: 0-48 hours after the end of surgery
The time to the first episode of vomiting (vomiting or retching) in the 0 to 48 hours following the end of surgery
Time frame: 0-48 hours after the end of surgery