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This is a multi-center, randomized, open-label, propofol-controlled exploratory clinical study. In this study, 20 ICU patients undergoing mechanical ventilation are expected to be enrolled and will be randomly assigned to the HSK3486 group and the propofol group in a 1:1 ratio. This study is not blinded as it is open-label.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK3486 | Experimental |
| |
| Propofol | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK3486 | Drug | Loading Dose:0.1 mg/kg,Maintenance Dose:Maintenance is started at 0.3 mg/kg/h, and the dose can be adjusted up and down by 0.05-0.1 mg/kg/h. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean duration of qualified sedation | the mean duration of RASS being in the range of -1 to -2 per hour during the study medication provided that no remedial medication is used | Within 96hours of administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recovery | the time for the subject to recover from sedation to full recovery of consciousness (RASS ≥ 0) after discontinuation of drug administration. | Within 24 hours after administration |
| Time to extubation |
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Inclusion Criteria:
Exclusion Criteria:
Patients known to be allergic to eggs, soy products, opioids and their antidotes, and Propofol; patient having contraindications to Propofol, opioids and their antidotes;
Patients who have received propofol for more than 3 days in the ICU or in the general ward before being transferred to the ICU before signing informed consent form;
Patients having the following medical history or evidence of any of the following at screening, which may increase sedation/anesthesia risk:
Pregnant or breastfeeding females: women or men of child-bearing potential who are unwilling to use contraception during the trial; subjects who are planning pregnancy within 1 month after the trial starts (including male subjects);
Have participated in any other clinical trials within 1 month prior to screening;
Other conditions that patients are judged by the investigator to be unsuitable for participating in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xinjiang Medical University | Xinjiang | China |
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| Propofol | Drug | Loading Dose:0.5 mg/kg,Maintenance Dose:Maintenance is started at1.5 mg/kg/h, and the dose can be adjusted up and down by 0.25-0.5mg/kg/h. |
|
the time from intubation (applicable to patients who undergoes intubation after entering the ICU)/ICU admission (applicable to patients with intubation before entering the ICU) to extubation or the time from drug discontinuation to extubation
| Within 24 hours after administration |
| ID | Term |
|---|---|
| C000730813 | HSK3486 |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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