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This is a multi-center, randomized, single-blind, propofol injectable emulsion parallel-controlled Phase III clinical study. A total of patients undergoing elective surgery are intended to be enrolled and randomly assigned to HSK3486 group and propofol group in a 2:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK3486 | Experimental |
| |
| Propofol | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK3486 | Drug | The initial Induction dose of HSK3486 is 0.4 mg/kg. The initial maintenance dose of HSK3486 is 0.8 mg/kg/h |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of anesthesia maintenance | During the maintenance of anesthesia, the subject is not recovered and no remedial anesthetic is used | During maintenance of general anesthesia on day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of anesthesia induction | During the induction of anesthesia, the subject achieves successful induction (i.e., MOAA/S ≤ 1) after administration of the study drug (up to 2 top-up doses), and no remedial anesthetic is used. | During induction of general anesthesia on day 1 |
| Percentage of time from the beginning of surgical skin incision to the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of HSK3486 and propofol in blood samples (sporadic sampling). | The end of the induction administration (to start of the maintenance administration) to 1~6 hours post-dose |
Inclusion Criteria:
In-patients undergoing non-emergency, non-cardiothoracic, and non-extracerebral elective surgeries with expected operation time ≥ 1 h and requiring tracheal intubation under general anesthesia (patients whose surgery type may affect the collection of BIS parameter should not be included);
Male or female, age ≥ 18 and ≤ 65 years old;
American Society of Anesthesiologists (ASA) class I-III;
Body mass index (BMI) ≥ 18 and ≤ 30 kg/m^2;
Vital signs in the screening period meeting the following criteria:
Subjects must understand the procedures and methods of this study, and be willing to provide informed consent and to complete the trial in strict accordance with study protocol.
Exclusion Criteria:
Patients with contraindications to general anesthesia or previous history of anesthesia accidents;
Known hypersensitivity to excipients and ingredients found in propofol injection and HSK3486 injectable emulsion (soybean oil, glycerin, triglycerides, egg lecithin, sodium oleate, and sodium hydroxide), benzodiazepines, opioids, rocuronium bromide, and sugammadex sodium; cross-reactivity to halogenated anesthetics, jaundice or unexplained fever from previous use of halogenated anesthetics; contraindications to propofol;
The following disease history or evidence that increases the risk of sedation/anesthesia is collected before/during screening:
Any of the following respiratory management risks before/during screening:
In receipt of any of the following drugs or therapies prior to screening:
Patient whose laboratory test results measured at screening reach the following criteria and are verified through re-examination:
Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception method during the trial; subjects who are planning pregnancy within 3 months 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,Sichuan University | Chengdu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36647565 | Derived | Liang P, Dai M, Wang X, Wang D, Yang M, Lin X, Zou X, Jiang K, Li Y, Wang L, Shangguan W, Ren J, He H. Efficacy and safety of ciprofol vs. propofol for the induction and maintenance of general anaesthesia: A multicentre, single-blind, randomised, parallel-group, phase 3 clinical trial. Eur J Anaesthesiol. 2023 Jun 1;40(6):399-406. doi: 10.1097/EJA.0000000000001799. Epub 2023 Jan 19. |
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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 | The initial Induction dose of propofol is 2.0 mg/kg. The initial maintenance dose of propofol is 5.0 mg/kg/h |
|
when bispectral index (BIS) is ≥ 40 and ≤ 60. |
| During maintenance of general anesthesia on day 1 |
| Time to recovery from anesthesia | 3 consecutive MOAA/S = 5. Record the time when MOAA/S = 5 is reached for the first time. | A period of time from discontinuation of the study drug to recovery after the end of surgery on day 1 |
| Time to respiratory recovery | Respiratory rate ≥ 8 breaths/min and the tidal volume ≥ 5 mL/kg | A period of time from discontinuation of the study drug to respiratory recovery after the end of surgery on day 1 |
| Time from discontinuation of the study drug to 3 consecutive Aldrete score ≥ 9. | A period of time from discontinuation of the study drug to 3 consecutive Aldrete score ≥ 9 on day 1 |
| Number of patients with adverse events | Safety endpoints | Pre-dose to 48 hours post-dose |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |