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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aprepitant Injection | Experimental | Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds |
|
| Placebo | Placebo Comparator | Before anesthesia induction, 4.4ml(0mg）was given by a single intravenous injection, which was completed within 30 seconds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprepitant Injection | Drug | Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 0-24 hours after the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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.） | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by NIH | Safety was assessed by Adverse events (AEs) were recorded after administration. | Day 0 to Day14 |
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;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiangdong chen, Doctor of Medicine(M.D.) | Contact | +86-027-85726300 | xiangdongchen2013@163.com | |
| Clinical Trials Information Group officer | Contact | 86-0311-69085587 | ctr-contact@cspc.cn |
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Parrallel Assignment
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| Aprepitant Injection Placebo | Drug | Before anesthesia induction, 4.4ml(0mg） was given by a single intravenous injection, which was completed within 30 seconds |
|
Significant nausea（defined as a visual analogue scale (VAS) nausea score≥4） |
| 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） | 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 | 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. | 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 | No vomiting or retching（Defined as whether or not use remedy treatment had no vomiting） | 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 | 0-48 hours after the end of surgery |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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