Post-operative Nausea and Vomiting (PONV)
Conditions
Brief summary
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).,
Detailed description
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).
Interventions
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
Sponsors
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parrallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Age ≥18 and ≤75 years old; 18 \< BMI≤30kg/m\^2, body weight ≥45kg; laparoscopic gynecologic or abdominal surgery under general anesthesia that was expected to last at least 1 hour. expected or agreed to stay in the hospital for 24 hours or more after surgery;
Exclusion criteria
diagnostic surgery; scheduled for postoperative transfer to an intensive care unit; requiring placement of a nasogastric or orogastric tube after surgery; Post-operative vomiting may pose significant risk;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response (CR) rates over 24 hours after the end of surgery | 0-24 hours after the end of surgery | Complete response (defined as no emetic episodes and no use of rescue therapy) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who have no vomiting or retching in the 0 to 24 hours following the end of surgery | 0-24 hours after 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 | 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 | 0-24 hours after the end of surgery | No nausea（defined as a visual analogue scale (VAS) nausea score \< 1.） |
| Time to treatment failure in the 0 to 24 hours following the end of surgery | 0-24 hours after 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. |
| Proportion of participants who have no vomiting or retching in the 0 to 48 hours following the end of surgery | 0-48 hours after the end of surgery | No vomiting or retching（Defined as whether or not use remedy treatment had no vomiting） |
| The time to the first episode of vomiting (vomiting or retching) in the 0 to 48 hours following the end of surgery | 0-48 hours after the end of surgery | — |
| Proportion of participants who have significant nausea in the 0 to 24 hours following the end of surgery | 0-24 hours after the end of surgery | Significant nausea（defined as a visual analogue scale (VAS) nausea score≥4） |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by NIH | Day 0 to Day14 | Safety was assessed by Adverse events (AEs) were recorded after administration. |
Contacts
Primary Contactxiangdong chen, Doctor of Medicine(M.D.)
Backup ContactClinical Trials Information Group officer
Outcome results
None listed