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This is a multi-center, randomized, single-blind, propofol-controlled phase III clinical study. In this study, ICU patients undergoing mechanical ventilation are expected to be enrolled and will be randomly assigned to the HSK3486 group and the propofol group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK3486 | Experimental | HSK3486 for Sedation |
|
| Propofol | Active Comparator | Propofol for Sedation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK3486 | Drug | Loading Dose:0.1 mg/kg, infused with 4 min ± 30 s; 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. Range of maintenance dose: 0.06-0.8 mg/kg/h |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of sedation | 1) The time period during which the RASS is in the range of +1 to -2 accounts for ≥ 70% of the total duration of study administration and 2) Remedial treatment is not used. | Within 24 hours of administration |
| Measure | Description | Time Frame |
|---|---|---|
| Mean qualified rate of sedation | Defined as the percentage of time period during which the RASS is in the range of +1 to -2 relative to the total duration of study administration | Within 24 hours of administration |
| Use of study drug |
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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 sedation 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 lactating females; women or men of child-bearing potential who are unwilling to use contraception through the study; subjects who are planning pregnancy within 1 month after the study (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 Sun Yat-sen University | Guangzhou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39455495 | Derived | Liu Y, Zuo L, Li X, Nie Y, Chen C, Liu N, Chen M, Wu J, Guan X. Early sedation using ciprofol for intensive care unit patients requiring mechanical ventilation: a pooled post-hoc analysis of data from phase 2 and phase 3 trials. Ann Intensive Care. 2024 Oct 26;14(1):164. doi: 10.1186/s13613-024-01390-3. | |
| 37272947 | Derived |
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| Propofol | Drug | Loading Dose:0.5 mg/kg, infused with 4 min ± 30 s Maintenance Dose:Maintenance is started at 1.5 mg/kg/h, and the dose can be adjusted up and down by 0.25-0.5 mg/kg/h. Range of maintenance dose: 0.3-4 mg/kg/h |
|
the loading doses of HSK3486 and propofol, mean maintenance dose and total dose per unit weight per hour of HSK3486 or propofol, and the number of dose modifications and the number of top up doses during the maintenance period
| Within 24 hours of administration |
| Dose of remedial drugs per unit weight | the mean dose per unit weight per hour of other sedatives used to maintain the target sedation (RASS within +1 to -2 points) | Within 24 hours of administration |
| Time to extubation | 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 |
| 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 |
| Incidence of adverse events | safety endpoits | From day -1 to 24 hours after administration |
| Liu Y, Peng Z, Liu S, Yu X, Zhu D, Zhang L, Wen J, An Y, Zhan L, Wang X, Kang Y, Pan A, Yan J, Zhang L, Liu F, Zeng J, Lin Q, Sun R, Yu J, Wang H, Yao L, Chen C, Liu N, Nie Y, Lyu J, Wu K, Wu J, Liu X, Guan X. Efficacy and Safety of Ciprofol Sedation in ICU Patients Undergoing Mechanical Ventilation: A Multicenter, Single-Blind, Randomized, Noninferiority Trial. Crit Care Med. 2023 Oct 1;51(10):1318-1327. doi: 10.1097/CCM.0000000000005920. Epub 2023 Jun 5. |
| 34417990 | Derived | Liu Y, Chen C, Liu N, Tong L, Nie Y, Wu J, Liu X, Gao W, Tang L, Guan X. Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical Ventilation: A Clinical Trial Study Protocol. Adv Ther. 2021 Oct;38(10):5412-5423. doi: 10.1007/s12325-021-01877-6. Epub 2021 Aug 21. |
| 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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