A Multicenter, Randomized, Double-blinded, Propofol-controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HSK3486 Injectable Emulsion for Induction of General Anesthesia in Adults Undergoing Elective Surgery.
Overview
- Phase
- Phase 3
- Intervention
- HSK3486
- Conditions
- Anesthesia
- Sponsor
- Haisco-USA Pharmaceuticals, Inc.
- Enrollment
- 255
- Locations
- 13
- Primary Endpoint
- Number of Participants With Successful Anesthesia Induction
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
This is a multicenter, randomized, double-blinded, propofol-controlled, Phase 3 clinical study to evaluate the efficacy and safety of HSK3486 for induction of general anesthesia in adults undergoing elective surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects undergoing elective surgery (nonemergency, noncardiothoracic, and nonintracranial surgery anticipated to last at least 1 hour ).
- •Males or females, aged ≥18 years old, with American Society of Anesthesiologists Physical Status (ASA PS) I to IV.
- •Body mass index (BMI) ≥18 kg/m
- •For all females of childbearing potential, negative pregnancy test at screening and baseline. Additionally, females of childbearing potential must agree to use birth control (such as condom, intrauterine device \[IUD\], abstinence) from the time of consent until 30 days post study drug administration.
- •Capable of understanding the procedures and methods of this study, willing to sign an Informed Consent Form, and to complete this study in strict compliance with the study protocol.
Exclusion Criteria
- •Contraindications to deep sedation/general anesthesia or a history of adverse reaction to sedation/general anesthesia.
- •Known to be allergic to eggs, soy products, opioids and their antidotes, or propofol; subject having contraindications to propofol, opioids, and their antidotes.
- •Medical condition or evidence of increased sedation/general anesthesia risk.
- •Management risks of respiratory tract and judged by the investigator to be unsuitable for inclusion in the study.
- •Any medication that has the potential to interact synergistically with propofol or HSK3486, including but not limited to all sedatives and hypnotics.
- •Laboratory parameters significantly out of range at screening.
- •Female subjects with a positive pregnancy test (serum or urine) at screening or baseline; lactating subjects; any subject planning to get pregnant within 1 month after the study (including the male subject's partner).
- •Judged by the investigator to have any other factors that make the subject unsuitable for participation in the study.
Arms & Interventions
HSK3486
HSK3486 for induction of general anesthesia.
Intervention: HSK3486
Propofol
Propofol for induction of general anesthesia.
Intervention: Propofol
Outcomes
Primary Outcomes
Number of Participants With Successful Anesthesia Induction
Time Frame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)
The primary outcome of interest was the success rate of anesthesia induction, defined by the proportion of subjects with successful anesthesia. A subject was considered successful for anesthetic induction if the following conditions were met: induction success Modified Observer's Assessment of Awareness/Sedation Scale (MOAA/S ≤1) after administration of study drug and 1 or less top-up dose required without using any rescue drugs. Where Grade 0 is no response after trapezius squeeze, Grade 1 responds only after painful trapezius squeeze and Grade 5 is completely awake responds to name spoken in normal tone.
Secondary Outcomes
- Subjects' NRS Pain Score(Up to 8 hours)
- Proportion of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression.(15 minutes from end of drug administration.)
- Proportion of Subjects With Any Injection-site Pain on Numeric Rating Scale.(From start of drug administration to MOAA/S ≤1 (up to 5 minutes))
- Time to Successful Induction of General Anesthesia.(From end of drug administration to MOAA/S ≤1 (up to 5 minutes))