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This is a Phase III, randomized, double-blind, propofol-controlled, parallel-design, multi-center study to evaluate the efficacy and safety of HSK3486 for sedation or anesthesia in patients undergoing colonoscopy and gastroscopy.
The study will enroll approximately 280 adults. The maximum study duration is anticipated to be up to nine months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK3486 | Experimental | 0.4mg/kg/0.2 mg/kg |
|
| Propofol | Active Comparator | 1.5mg/kg/0.75mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK3486 | Drug | HSK3486 intravenous (iv) 0.4 mg/kg for induction, and 0.2 mg/kg top-ups for maintenance. |
|
| 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 |
|---|---|---|
| The success rate of the gastroscopy procedure | from the first dose of the study drug to removal of gastroscope on day 1 | |
| The success rate of the colonoscopy and gastroscopy procedure | from the first dose of the study drug to rem oval of colonoscope and gastroscope on day 1 |
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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)total bilirubin≥ 1.5×ULN; 6) 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 |
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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 1.5 mg/kg for induction, and 0.75 mg/kg top-ups for maintenance. |
|
| Time to induction of sedation or anaesthesia | from the first dose of the study drug to the first MOAA/S scores≤1 on day 1 |
| Time to start of procedure | From first dose of study drug until insertion of colonoscope or gastroscope on day 1 |
| Time to fully alert | from the removal of colonoscopy or gastroscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1 |
| Time to discharge | from the removal of colonoscopy or gastroscopy procedure, until the first of three consecutive Aldrete scores of more than or equal to 9 on day 1 |
| Sedation/anesthesia satisfaction, satisfaction assessment of subjects, anesthesiologists, and endoscopic physicians | from time to fully alert, until time to discharge on day 1 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |