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A double-blind, randomized, active controlled, multi-center, parallel group study comparing HSK3486 with Propofol, in patients undergoing a colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK3486 0.4/0.2mg/kg ,0.5mg/kg/0.15mg/kg | Experimental |
| |
| Propofol 2.0/1.0mg/kg group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK3486 | Drug | HSK3486 intravenous (iv) 0.4(0.5) mg/kg for induction, and 0.2 (0.15)mg/kg top-ups for maintenance. 0.3(0.375) mg/kg for induction and 0.15 (0.113)mg/kg for maintenance in adults of 65-70 years old |
| Measure | Description | Time Frame |
|---|---|---|
| Success of colonoscopy procedure | Measured by completion of colonoscopy, no requirement for an alternative sedative or anesthesia drug and no requirement for more than 5 doses of study drug within any 15 minute period. | from the first dose of the study drug to removal of colonoscope on day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to start of procedure | From first dose of study drug until insertion of colonoscope on day 1 | |
| The success rate of the colonoscopy procedure | The number of patients who successfully completed the colonoscopy procedure accounted for the proportion of all patients in the dose group |
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Inclusion Criteria:
Exclusion Criteria:
1) neutrophil count≤ 1.5×109/L; 2)platelet≤ 80×109/L; 3)hemoglobin≤ 90 g/L; 4)aspartate aminotransferase≥ 1.5×ULN; 5) serum creatinine≥ 1.2×ULN. 9. Pregnant women or female patients with a positive serum or urine human chorionic gonadotropin pregnancy test at screening or baseline or lactating female patients.
10. Patients with an inability to communicate well with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Changde | China | ||||
| The Second Xiangya Hospital of Central South University |
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| ID | Term |
|---|---|
| C000730813 | HSK3486 |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | Propofol iv 2.0 mg/kg for induction, and 1.0 mg/kg top-ups for maintenance. 1.5 mg/kg for induction and 0.75mg/kg for maintenance in adults of 65-70 years old. |
|
| from the first dose of the study drug to removal of colonoscope on day 1 |
| Time to fully alert | from the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1 |
| Time to discharge | from the removal of colonoscopy procedure, until the first of three consecutive Aldrete scores of more than or equal to 9 on day 1 |
| Application of study drug and alternative medication | total dosages of study drug and alternative medication | during the colonoscopy procedure on day 1 |
| Changsha |
| China |
| The Third Xiangya Hospital of Central South University | Changsha | China |
| Sichuan Provincial People's Hospital | Chengdu | China |
| Shanghai Fengxian District Central Hospital | Shanghai | China |
| The second Affiliated Hospital of Wenzhou Medical University | Wenzhou | China |
| Union Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China |
| General Hospital of Ningxia Medical University | Yinchuan | China |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |