A Phase II, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of HRS-9190 for Injection as a Neuromuscular Blocking Agent for Tracheal Intubation During General Anesthesia Induction in Adult Patients Undergoing Elective Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 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 with tracheal intubation. 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, duration of action, and recovery profile of neuromuscular blockade. 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 for tracheal intubation, 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 65 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
- •Scheduled for specific high-risk surgical procedures
- •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
- •Pregnant or nursing women
- •Unwilling to use birth control during the specified period
研究组 & 干预措施
Treatment group A: HRS-9190
干预措施: HRS-9190 (Drug)
Treatment group B: HRS-9190
干预措施: HRS-9190 (Drug)
Treatment group C: Rocuronium Bromide Injection.
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
- Recovery Index (T1 25% to 75% and T1 5% to 95%)(within 2 hours after administration of research drug)
- Time to Maximum Inhibition (Onset Time)(From start of study drug administration until the time when T1 reaches 0% (maximum suppression), Estimated within 5 minutes)
- Time to Successful Tracheal Intubation(From start of study drug administration to the completion of tracheal intubation, Estimated within 5 minutes)
- Time to Recovery of T1 to 10%/25% of Baseline(From start of study drug administration until the time when T1 recovers to 10% /25% of its baseline value, Estimated within 30 minutes)
- Time to Recovery of Train-of-Four Ratio (TOFr) to 0.4/0.7/0.9(From start of study drug administration until the time when the TOFr recovers to 0.4/0.7/0.9, Estimated from 15 to 90 minutes)