A Phase II, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bolus-Administered HRS-9190 Versus Rocuronium for Maintaining Neuromuscular Blockade During General Anesthesia in Adults Undergoing Elective Surgery.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Time from Last Dose to Recovery of TOFr to 0.9
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 measure the duration from the last dose of the study drug until the recovery of neuromuscular function to a specific level (TOFr ≥ 90%). 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
- •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 F: Rocuronium under Intravenous Anesthesia.
干预措施: Rocuronium (Drug)
Treatment group D: HRS-9190 under Intravenous Anesthesia
干预措施: HRS-9190 (Drug)
Treatment group E: Rocuronium under Inhalational Anesthesia
干预措施: Rocuronium (Drug)
Treatment group A: HRS-9190 under Inhalational Anesthesia
干预措施: HRS-9190 (Drug)
Treatment group B: HRS-9190 under Inhalational Anesthesia
干预措施: HRS-9190 (Drug)
Treatment group C: HRS-9190 under Intravenous Anesthesia
干预措施: HRS-9190 (Drug)
结局指标
主要结局
Time from Last Dose to Recovery of TOFr to 0.9
时间窗: From the administration of the last dose of the study drug until TOFr ≥ 0.9 is achieved, assessed intraoperatively and in the recovery period, up to 2 hours.
The duration (in minutes) from the administration of the last dose of the neuromuscular blocking agent to the recovery of the Train-of-Four ratio (TOFr) to 90% or greater
次要结局
- Duration of Action after Bolus Dose(s)(For each bolus dose: from administratin until specified recovery points, assessed intraoperatively, up to 2 hours.)
- Time from Last Dose to Specific TOFr Recovery Milestones(From the administration of the last dose of the study drug until specified TOFr values are achieved, assessed intraoperatively and in recovery, up to 2 hours.)
- Percentage of Time with Target Neuromuscular Block(From the first administration of the study drug until the end of the last maintenance dose requirement, assessed intraoperatively, up to 6 hours.)
- Time to Successful Airway Device Placement(From administration of the initial intubating dose to completion of tracheal intubation or laryngeal mask insertion, assessed at induction, approximately 2-5 minutes.)
- Onset Time after Bolus Dose(s)(For each bolus dose: from administration to maximum T1 depression, assessed intraoperatively, up to 6 hours.)
- Time from Last Dose to Airway Device Removal(From the administration of the last dose of the study drug to tracheal extubation or laryngeal mask removal, assessed at the end of surgery until device removal, up to 2 hours.)
- Recovery Index(After the last dose: from T1=25% to T1=75%, and from T1=5% to T1=95%, assessed intraoperatively and in recovery, up to 2 hours.)
- 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.)