Efficacy and Safety of HSK3486 Compared to Propofol in Induction of General Anesthesia in Adults Having Elective Surgery
Condition: Anesthesia
Intervention: HSK3486; Propofol
Intervention description: HSK3486 for induction of general anesthesia.; Propofol for induction of general anesthesia.
Intervention MeSH terms: Propofol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Anesthesia; Elective surgery; Propofol

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.
    

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/m2.

          -  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.