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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 13
- 主要终点
- Number of Participants With Successful Anesthesia Induction
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
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; 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.
研究组 & 干预措施
HSK3486
HSK3486 for induction of general anesthesia.
干预措施: HSK3486 (Drug)
Propofol
Propofol for induction of general anesthesia.
干预措施: Propofol (Drug)
结局指标
主要结局
Number of Participants With Successful Anesthesia Induction
时间窗: 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.
次要结局
- 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))