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The study is being conducted to evaluate the efficacy, and safety of HRS5580 for preventing of postoperative nausea and vomiting in adults. To explore the reasonable dosage of HRS5580 for postoperative nausea and vomiting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS5580 | Experimental |
| |
| Treatment group B: HRS5580 | Experimental |
| |
| Treatment group C: HRS5580 | Experimental |
| |
| Treatment group D: Ondansetron | Active Comparator |
| |
| Treatment group E: blank preparation. | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS5580 | Drug | HRS5580; low dose |
| |
| HRS5580 |
| Measure | Description | Time Frame |
|---|---|---|
| No vomiting rate within 72 hours after extubation | at 72 hours after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (defined as the proportion of subjects without vomiting and receiving no rescue therapy) at 24, 48, 72, 96, and 120 hours after extubation | at24, 48, 72, 96, and 120 hours after extubation | |
| No vomiting at 24, 48, 96, and 120 hours after extubation, |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China | ||
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
HRS5580; middle dose |
|
| HRS5580 | Drug | HRS5580; middle dose |
|
| Ondansetron | Drug | Ondansetron |
|
| blank preparation | Drug | blank preparation. |
|
| at 24, 48, 96, and 120 hours after extubation |
| Proportion of subjects who did not experience significant nausea within 24, 48, 72, 96, and 120 hours after extubation | at 24, 48, 72, 96, and 120 hours after extubation |
| Proportion of participants not receiving rescue medication within 24, 48, 72, 96, and 120 hours of extubation | at 24, 48, 72, 96, and 120 hours of extubation |
| Third Xiangya Hospital of Central South University |
| Changsha |
| Hu'nan |
| 410013 |
| China |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |