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This is a Phase IIa, open-label, propofol-controlled ,dose-escalation, multi-center Study to evaluate the tolerance, efficacy and safety of HSK3486 for induction of general anesthesia in elective surgery patients.This study is consisted of two cohorts, dose-escalation and dose-expansion cohorts. The doses in dose- expansion cohort were selected from dose-escalation results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK3486 | Experimental | Dose Escalation Cohort: 0.1 mg/kg, 0.2 mg/kg, 0.3mg/kg 0.4 mg/kg 0.5 mg/kg, 0.6 mg/kg, 0.7mg/kg, 0.8 mg/kg Dose Expansion Cohort: 0.3 mg/kg and 0.5 mg/kg. |
|
| Propofol | Active Comparator | Dose Escalation Cohorts:2.0mg/kg and 2.5mg/kg; Dose Expansion Cohorts: 2.0mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK3486 | Drug | For induction of general anesthesia In dose escalation cohort: Starting from 0.4mg/kg, up-titration dose by 0.1mg/kg until 0.8mg//kg or down-titration dose by 0.1mg/kg until 0.1mg/kg based on the efficacy and safety results. |
| Measure | Description | Time Frame |
|---|---|---|
| The success rate of induction of general anesthesia | To find the MTD or the RP2D of HSK3486 in the induction of general anesthesia, the success rate of induction of general anesthesia is the primary outcome measurement. | during induction of general anesthesia on day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time from start of IMP administration to loss of eyelash reflex | during induction of general anesthesia on day 1 | |
| Time from start of IMP administration to loss of consciousness | during induction of general anesthesia on day 1 |
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Inclusion Criteria:
Exclusion Criteria:
1) AST and ALT≥ 2×ULN; 2)TBIL≥ 1.5×ULN; 3)Hb≤ 90g/L; 4)ANC≤1.5×109/L; 5) PLT≤80×109/L; 6) serum creatinine≥ 1.5×ULN.
8. Patients with a history of drug or ethanol abuse with the past 3 months. 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. 10. Patients with a positive Allen 's test who collected arterial blood for PK study.
11. Patients with respiratory management difficulties. 12. 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 |
|---|---|---|---|---|---|---|
| The 2nd Affiliated Hospital of WMU | Wenzhou | Zhejiang | 325027 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36680620 | Derived | Zhu Q, Luo Z, Wang X, Wang D, Li J, Wei X, Tang J, Yao S, Ouyang W, Zhang W, Zuo Y, Wang X, Liu J. Efficacy and safety of ciprofol versus propofol for the induction of anesthesia in adult patients: a multicenter phase 2a clinical trial. Int J Clin Pharm. 2023 Apr;45(2):473-482. doi: 10.1007/s11096-022-01529-x. Epub 2023 Jan 21. |
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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 | For induction of general anesthesia |
|
| Time from start of IMP administration to intubation and the intubation reaction | during induction of general anesthesia on day 1 |
| Mini-Mental State Examination (MMSE) total scores(0-30) by time point | Change from baseline in Mini-Mental State Examination (MMSE) total score | Pre-dose to 48 hours post-dose |
| change from baseline in blood pressure (systolic, diastolic and mean arterial pressure) | safety endpoits | pre-dose to 20 minutes post-dose |
| change from baseline in heart rate | safety endpoits | pre-dose to 20 minutes post-dose |
| change from baseline in arterial oxygen saturation | safety endpoits | pre-dose to 20 minutes post-dose |
| Number of patients with adverse events | safety endpoits | Pre-dose to 48 hours post-dose |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |