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This is a multicenter, randomized, double-blind, placebo-controlled Dose-Finding study. About 200 subjects undergoing elective laparoscopic abdominal or gynecological surgery are planned to be enrolled and randomized into four groups by a ratio of 1:1:1:1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK21542-60μg | Experimental |
| |
| HSK21542-120μg | Experimental |
| |
| HSK21542-180μg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK21542-60μg | Drug | HSK21542 injection of 60 μg was administered once within 15 min before the end of surgery, and was administered by intravenous bolus injection for no less than 30 s; |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response | The primary efficacy analysis was the complete response (CR)within the 24 hours after the end of surgery (CR was defined as no vomiting or retching and on use of rescue medication) | 24 hours after the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects experiencing nausea within 24 hours after the end of surgery | Nausea (defined as a feeling of urgency to vomit, characterized by merycism and/or urgent vomiting) measured on a 0-10 verbal response scale[VAS], where 0=no nausea at all and 10=the worst nausea that cannot be tolerated | 24 hours after the end of surgery |
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Inclusion Criteria:
Exclusion Criteria:
Prior and concomitant diseases
History or evidence of any of the following diseases prior to screening:
Prior and concomitant medications
Any of the following medications or treatments have been used at screening:
Laboratory and other tests
Laboratory test indicators at screening meet the following criteria:
Other conditions
Subjects anticipated to require continued endotracheal intubation after the end of surgery;
Subjects anticipated to require the insertion of nasal or oral gastric tubes after the end of surgery;
Subjects with a history of serious drug allergies or those allergic to the investigational drugs specified in the protocol;
Subjects with a history of drug abuse, drug addiction, or alcoholism within 3 months prior to screening, where alcoholism is defined as consuming > 2 units of alcohol on average daily (1 unit = 360 mL of beer with 5% alcohol, 45 mL of liquor with 40% alcohol or 150 mL of wine);
Subjects with nausea, retching, or vomiting within 24 h prior to induction of anesthesia (except for those caused by bowel preparation);
Subjects who have participated in any investigational trial (defined as receiving investigational drug or placebo) within 3 months prior to screening;
Female subjects who are pregnant or breastfeeding; female or male subjects of child-bearing potential are unwilling to use contraception throughout the entire study period and for 3 months after the study completion;
Subjects judged by the investigator to be unsuitable for participating in this clinical trial for any other factors.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Provincial People's Hospital | Sichuan | China |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| HSK21542-120μg | Drug | HSK21542 injection of 120 μg was administered once within 15 min before the end of surgery, and was administered by intravenous bolus injection for no less than 30 s; |
|
| HSK21542-180μg | Drug | HSK21542 injection of 180 μg was administered once within 15 min before the end of surgery, and was administered by intravenous bolus injection for no less than 30 s; |
|
| Placebo | Drug | A placebo was administered once within 15 min before the end of surgery, and was administered by intravenous bolus injection for no less than 30 s; |
|
| Proportion of subjects experiencing significant nausea within 24 hours after the end of surgery |
Significant nausea is defined as VAS score ≥ 4 cm |
| 24 hours after the end of surgery |
| Proportion of subjects experiencing vomiting within 24 hours after the end of surgery | vomiting [even with the expulsion of scanty gastric contents] or retching [presence of vomiting muscle movement without the expulsion of gastric contents]) | 24 hours after the end of surgery |
| Proportion of subjects using rescue medication within 24 hours after the end of surgery | Any drug given in the post-operative period with the intention of providing anti-emetic rescue is counted as rescue anti-emetic medication | 24 hours after the end of surgery |
| Time to first occurrence of vomiting or rescue therapy (whichever occurs first) within 24 hours after the end of surger | Vomiting includes vomiting or retching | 24 hours after the end of surgery |
| The cumulative morphine doses administered within 24 hours after the end of surgery | Morphine as the postoperative analgesics | 24 hours after the end of surgery |
| PONV Satisfaction Score by Subject and Investigator | Satisfaction Score rating range 0-10,where 0=not satisfactory at all, and 10=the most satisfactory | 24 hours after the end of surgery |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |