2023-507009-32-00已完成3 期
A Global 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
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 9
- 主要终点
- Success rate of general anesthesia induction: A successful general anesthesia induction will meet both of the following conditions: a) Induction success (MOAA/S ≤1) after administration of the study drug, and b) One or less top-up doses required without using any rescue drugs.
研究概览
简要总结
To demonstrate HSK3486 0.4/0.2 mg/kg (0.4 mg/kg intravenous [IV] slow injection for the first dose, an additional 0.2 mg/kg if needed) is non-inferior to propofol 2.0/1.0 mg/kg (2.0 mg/kg IV slow injection for first dose, an additional 1.0 mg/kg if needed) in success of induction of general anesthesia in adults undergoing elective surgery.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Subjects undergoing elective surgery (non emergency, noncardiothoracic, 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. For ASA-PS IV subjects, clinical status must be optimized at time of preoperative anesthesia evaluation per judgement of the anesthesiologist.
- •BMI ≥18 kg/m
- •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 effective contraception 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 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.
- •Patients with psychiatric/mental disorders must be considered stable on treatment (e.g., SSRIs, SNRIs, TCAs, MAOIs, psychotherapy) per investigator judgement, and no hospitalizations and urgent care due to the underlying psychiatric pathology for at least 12 months.
- •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.
排除标准
- •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
- •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
- •Female subjects with a positive pregnancy test at screening (serum) or baseline (urine); 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.
结局指标
主要结局
Success rate of general anesthesia induction: A successful general anesthesia induction will meet both of the following conditions: a) Induction success (MOAA/S ≤1) after administration of the study drug, and b) One or less top-up doses required without using any rescue drugs.
Success rate of general anesthesia induction: A successful general anesthesia induction will meet both of the following conditions: a) Induction success (MOAA/S ≤1) after administration of the study drug, and b) One or less top-up doses required without using any rescue drugs.
次要结局
- The proportion of subjects with any injection-site pain at time of drug administration on the Numeric Rating Scale (NRS ≥1).
- The proportion of subjects with successful induction who maintain the desired depth of anesthesia for general elective surgery, and without significant cardiac and respiratory depression within 15 minutes post initiation start of study drug administration.
研究者
Clinical Trial Info
Scientific
Haisco-USA Pharmaceuticals Inc.
研究点 (9)
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