Safety and Efficacy of HSK3486 Compared to Propofol for Induction of General Anesthesia in Adults With Elective Surgery

Inclusion criteria

• ✓. Subjects undergoing elective surgery (non-emergency, non-cardiothoracic, and non-intracranial surgery anticipated to last at least 1 hour) requiring endotracheal intubation and inhalation general anesthesia during the maintenance period. Duration of surgery is defined as time from study drug administration to time of transfer from operating room to recovery room or PACU.
• ✓. Males or females, aged ≥18 years old, with ASA PS I to IV (Appendix 6). For ASA-PS IV subjects, clinical status must be optimized at time of preoperative anesthesia evaluation per judgement of the anesthesiologist.
• ✓. BMI ≥18 kg/m2.
• ✓. Vital signs at screening: RR ≥10 and ≤24 breaths/min; SpO2 ≥92% in ambient air; SBP ≥90 and ≤160 mmHg; DBP ≥55 and ≤ 100 mmHg; HR ≥55 (or ≥50 if subjects are on beta blockers) and ≤100 beats/min.
• ✓. For all women of childbearing potential, negative serum pregnancy test within the screening period and negative urine pregnancy test at baseline (Day 1). Additionally, women of childbearing potential\* and male subjects with female partners of childbearing potential must agree to use contraception as defined in 7.3.4 from the time of consent until 30 days post study drug administration.
• ✓. For subjects with known hypothyroidism and/or on thyroid-hormone replacement treatment (i.e., thyroxine), or subjects suspected to have thyroid dysfunction based on clinical laboratory and physical exam, a TSH must drawn and be within normal levels.
• ✓. Capable of understanding the procedures and methods of this study, willing to sign an Informed Consent Form (ICF), and able to complete this study in strict compliance with the study protocol.
• ✓. Willing to comply with the site's COVID guidelines and testing requirements as applicable.

Exclusion criteria