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This is a multi-center, randomized, double-blind, propofol-controlled phase III clinical trial. The primary objective is to compare the efficacy and safety between propofol and HSK3486 for the induction of general anesthesia in elective surgery subjects, so as to provide reference for marketing registration of HSK3486.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK3486 | Experimental | 0.4mg/kg/0.2 mg/kg |
|
| Propofol | Active Comparator | 2.0mg/kg/1.0mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK3486 | Drug | Initial dose of 0.4 mg/kg followed by 0.2 mg/kg if needed. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The success rate of induction of anesthesia | During induction of general anesthesia on day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to successful anesthetic induction | From the initial administration of the investigational drug to the first time when MOAA/S is ≤1 on day 1 | |
| Time to loss of eyelash reflex | From the initial administration of the investigational drug to loss of eyelash reflex on day 1 |
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Inclusion Criteria:
Exclusion Criteria:
Patients with contraindications to general anesthesia or previous history of anesthesia accidents;
Known hypersensitivity to excipients and ingredients found in propofol and HSK3486 injections (soybean oil, glycerin, triglycerides, egg lecithin, sodium oleate, and sodium hydroxide), benzodiazepines, opioids, rocuronium bromide, sevoflurane, atropine, and neostigmine; cross-reactivity to halogenated anesthetics, jaundice or unexplained fever from previous use of halogenated anesthetics; contraindications to propofol;
Medical history or evidence of any of the following prior to screening/at baseline, which may increase sedation/anesthesia risk:
Any one of the following respiratory risks before/during screening:
In receipt of any of the following drugs or therapies prior to screening:
Laboratory results meeting any of the following criteria during screening/at baseline, confirmed by re-examination:
Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial; subjects who are planning pregnancy within 1 month after the completion of the trial (including male subjects);
Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | China |
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| Propofol |
| Drug |
Initial dose of 2.0 mg/kg followed by 1.0 mg/kg if needed |
|
| Use of the investigational drug and alternative drugs | During induction of general anesthesia on day 1 |
| Use of the alternative drugs | During induction of general anesthesia on day 1 |
| Changes in bispectral index (BIS)(score:0~100) | During induction of general anesthesia on day 1 |
| Number of patients with adverse events | Safety endpoints | Pre-dose to 48 hours post-dose |
| 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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