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

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• 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; subjects having contraindications to propofol, opioids, and their antidotes. In cases where the only previous reaction to opioids was itching or nausea, subjects need not be excluded if the investigator believes the subject is not truly allergic to opioids.
• Medical condition or evidence of increased sedation/general anesthesia risk as follows: a) Cardiovascular disorders: uncontrolled hypertension (SBP >160 mmHg and/or DBP >100 mmHg) with or without antihypertensive therapy (antihypertensive therapy should be stable for 1 month prior to screening), serious arrhythmia (including the subjects with implanted pace makers), unstable heart failure, Adams-Stokes syndrome (i.e., syncope or near syncope due to cardiac arrythmia), unstable angina, myocardial infarction occurring within 6 months prior to screening, history of tachycardia/bradycardia requiring medications, third degree atrioventricular block or QT interval corrected for HR using Fridericia’s formula (QTcF) ≥450ms for males and ≥470ms for females. b) History of severe obstructive lung disease (i.e., forced expiratory volume in 1 second [FEV1] <50% predicted), history of bronchospasm requiring treatment in a hospital emergency room or hospitalization occurring within 3 months prior to screening, developing acute respiratory tract infection within 2 weeks prior to baseline (such as symptoms of fever, shortness of breath, wheezing, nasal congestion, and cough). c) Cerebrovascular disease: subject with a history of serious craniocerebral injury, convulsion, seizure disorder, intracranial hypertension, cerebral aneurysm, or stroke. d) Patients with psychiatric/mental disorders who have not been on a stable treatment regimen (e.g., SSRIs, SNRIs, TCAs, MAOIs, psychotherapy) per investigator judgement, for at least 12 months or who have been hospitalized or had emergent/urgent care due to underlying psychiatric pathology within the last 12 months. e) Uncontrolled clinically significant conditions of liver (e.g., severe hepatic insufficiency defined as Childs- Pugh class C), kidney, gastrointestinal tract, blood system, nervous system, or metabolic system diseases, judged by the investigator to be unsuitable for involvement in the study. f) History of uncontrolled diabetes in the opinion of the investigator. g) History of alcohol abuse within 3 months prior to screening, where alcohol abuse refers to daily alcohol drinking >2 units of alcohol (1 unit = 360 mL of beer or 45 mL of spirit with a strength of 40% or 150 mL of wine). h) History of drug abuse that, in the opinion of the investigator, may confound the interpretation of safety or efficacy in a study subject. i) For subjects with known hypothyroidism and/or on thyroid-hormone replacement treatment (i.e. thyroxine), or subjects suspected to have thyroid disfunction based on clinical laboratory and physical exam who has a TSH value outside the normal range.
• Management risks of respiratory tract and judged by the investigator to be unsuitable for inclusion in the study as follows: a) Asthma must be stable: stable doses of asthma medications for the past 6 months, no requirement for rescue inhalers or oral steroids within past 6 months, not evaluated in emergency department, urgent care, or hospitalized for an asthma attack within past 1 year. b) History (or family history) of malignant hyperthermia. c) Any previous failure of tracheal intubation. d) Judged to have a difficult airway for endotracheal intubation in the opinion of the Investigator based on parameters such as modified Mallampati score (Grade III or IV), neck mobility, short thyromental distance, and/or history of difficult intubation.
• Any medication that has the potential to interact synergistically with propofol or HSK3486, including but not limited to all sedatives and hypnotics (e.g., benzodiazepines and opioids) taken within 5 half-lives prior to Day 1.
• Laboratory parameters measured at screening with the following levels: a) Neutrophil count ≤1.5 x 10^9/L b) Platelet count <80 x 10^9/L c) Hemoglobin <90 g/L (without blood transfusion within 14 days) d) Alanine transaminase and/or aspartate transaminase ≥2.0 x upper limit of normal (ULN) e) Total bilirubin ≥2.0 x ULN f) Severe renal impairment defined by creatinine clearance (CrCl) ≤30 mL/min