A Study to Evaluate the Efficacy and Safety of HSK3486 in the Induction of General Anesthesia
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|ClinicalTrials.gov Identifier: NCT04511728|
Recruitment Status : Completed
First Posted : August 13, 2020
Last Update Posted : May 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Induction and Maintenance of General Anesthesia||Drug: HSK3486 Drug: Propofol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multi-center, Randomized, Single-blind, Propofol Injectable Emulsion Parallel-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HSK3486 Injectable Emulsion in the Induction of General Anesthesia in Patients Undergoing Elective Surgery|
|Actual Study Start Date :||November 24, 2020|
|Actual Primary Completion Date :||December 31, 2020|
|Actual Study Completion Date :||January 25, 2021|
The initial Induction dose of HSK3486 is 0.4 mg/kg. The initial maintenance dose of HSK3486 is 0.8 mg/kg/h
|Active Comparator: Propofol||
The initial Induction dose of propofol is 2.0 mg/kg. The initial maintenance dose of propofol is 5.0 mg/kg/h
- Success rate of anesthesia maintenance [ Time Frame: During maintenance of general anesthesia on day 1 ]During the maintenance of anesthesia, the subject is not recovered and no remedial anesthetic is used
- Success rate of anesthesia induction [ Time Frame: During induction of general anesthesia on day 1 ]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.
- Percentage of time from the beginning of surgical skin incision to the end of surgery [ Time Frame: During maintenance of general anesthesia on day 1 ]when bispectral index (BIS) is ≥ 40 and ≤ 60.
- Time to recovery from anesthesia [ Time Frame: A period of time from discontinuation of the study drug to recovery after the end of surgery on day 1 ]3 consecutive MOAA/S = 5. Record the time when MOAA/S = 5 is reached for the first time.
- Time to respiratory recovery [ Time Frame: A period of time from discontinuation of the study drug to respiratory recovery after the end of surgery on day 1 ]Respiratory rate ≥ 8 breaths/min and the tidal volume ≥ 5 mL/kg
- Time from discontinuation of the study drug to 3 consecutive Aldrete score ≥ 9. [ Time Frame: 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 [ Time Frame: Pre-dose to 48 hours post-dose ]Safety endpoints
- Concentrations of HSK3486 and propofol in blood samples (sporadic sampling). [ Time Frame: The end of the induction administration (to start of the maintenance administration) to 1~6 hours post-dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04511728
|West China Hospital，Sichuan University|