A Phase III, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bolus-Administered HRS-9190 Versus Rocuronium for Tracheal Intubation and Maintaining Neuromuscular Blockade During General Anesthesia in Adults Undergoing Elective Surgery
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Intubation conditions
研究概览
简要总结
The study will enroll adult patients scheduled for elective surgery requiring general anesthesia. Participants will be randomly assigned to receive either HRS-9190 for Injection or Rocuronium. The primary objective is to assess the efficacy of HRS-9190 in providing adequate neuromuscular blockade for successful tracheal intubation. Secondary objectives include evaluating the onset time and duration of action following each dose, the total time adequate muscle relaxation is maintained during surgery, and the detailed pattern of neuromuscular recovery. Safety assessments will include monitoring of adverse events, vital signs, laboratory parameters, and other safety indicators throughout the study period. The hypothesis of this study is that HRS-9190 for Injection could provide effective neuromuscular relaxation, with a satisfied safety profile in the target patient population.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent
- •Subjects requiring elective general anesthesia surgery
- •Meet specified age and body mass index (BMI) criteria
- •Conform to the ASA Physical Status Classification
- •Use of highly effective contraception for a specified period if applicable
排除标准
- •History of significant neuromuscular, cardiovascular, respiratory, or neurological disorders
- •History of conditions affecting drug metabolism or anesthesia risk
- •Abnormal laboratory values indicating significant clinical abnormalities
- •Positive serology for specified infectious diseases
- •Known hypersensitivity to related medications
- •Recent use of medications interfering with neuromuscular function
- •History of mental illness, cognitive impairment, or epilepsy
- •Participation in another clinical trial within a specified period
- •Any other condition deemed unsuitable by the investigator
研究组 & 干预措施
Treatment group B
干预措施: Rocuronium (Drug)
Treatment group A
干预措施: HRS-9190 (Drug)
结局指标
主要结局
Intubation conditions
时间窗: Within 5 minutes after administration of the study drug
Proportion of subjects with excellent or good intubation conditions as assessed by the Cooper score
次要结局
- Time from last dose to recovery from T1% 25% to TOFr ≥90%(Within 2 hours after last dose administration)
- Time to Tracheal Intubation(Within 5 minutes after administration of study drug during induction)
- Onset Time(Within 30 minutes after each dose of study drug)
- Duration of Action(Up to 2 hours after each dose of study drug)
- Percentage of Time Maintaining Target Neuromuscular Blockade Level(Throughout the drug administration period, up to 6 hours)
- Time to Tracheal Extubation(up to 2 hours after the last dose of study drug)
- Recovery Index(up to 2 hours after the last dose of study drug)
- Anesthesiologist's Overall Satisfaction Score(Assessed at the end of the surgical procedure, within 1 hour.)
- Surgeon's Overall Satisfaction Score(Assessed at the end of the surgical procedure, within 1 hour.)