A Phase 2, Randomized, Double-Blind, Active-Controlled, Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assessment of Intubation Conditions
研究概览
简要总结
Assessment of Intubation conditions following administration of neuromuscular blocking agents; BX1000 (investigational) or rocuronium (active control).
详细描述
Intubation conditions will be assessed in anesthetized subjects undergoing an elective surgical procedure utilizing general anesthesia. Following administration of IV anesthesia, subjects will have electromyography (EMG) neuromuscular monitoring device applied prior to administration of neuromuscular blocking agent (NMBA). NMBA will be administered and assessment of intubation conditions will begin 60 seconds after administration according to the methods defined in Viby-Mogensen 1996; assessment will be repeated at 90 and 120 seconds after administration when intubation has not already been completed.
After intubation is completed, subjects will progress to have their elective surgery completed and will be maintained under general anesthesia until neuromuscular function is recovered. Once recovered from anesthesia and extubation, subjects will be monitored in a recovery area until they are suitable to be discharged to the inpatient floor, after which time they may be discharged at the clinical discretion of the investigator.
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)
盲法说明
Double-blind, active controlled
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
- 是
入选标准
- •Providing informed consent
- •Undergoing elective surgery utilizing IV general anesthesia
- •Normal airway assessment
排除标准
- •Unstable disease or emergency surgical conditions
- •Known hypersensitivity to rocuronium, other NMB or study medications
- •History of anaphylaxis
- •History of neuromuscular junction disease
- •Personal or family history of malignant hyperthermia or pseudocholinesterase deficiency
- •Diagnosed or suspected sleep apnea
- •History of prior anesthetic complications
研究组 & 干预措施
BX1000 0.15 mg/kg
BX1000 0.15 mg/kg IV Bolus
干预措施: BX1000 (Drug)
BX1000 0.25 mg/kg
BX1000 0.25 mg/kg IV Bolus
干预措施: BX1000 (Drug)
BX1000 0.35 mg/kg
BX1000 0.35 mg/kg IV Bolus
干预措施: BX1000 (Drug)
Rocuronium 0.6 mg/kg
Rocuronium bromide 0.6 mg/kg IV Bolus
干预措施: Rocuronium Bromide (Drug)
结局指标
主要结局
Assessment of Intubation Conditions
时间窗: Within 2 minutes after administration
Assessment of Intubation Conditions (Poor, Good, Excellent) Following Administration of Neuromuscular Blocking agent
次要结局
- Assessment of Safety And Tolerability - Adverse Events(Within 30 days after administration)
- Assessment of Safety And Tolerability - Blood Pressure(Within 30 days after administration)
- Assessment of Safety And Tolerability - Heart Rate(Within 30 days after administration)
- Assessment of Safety And Tolerability - Blood Oxygen Saturation(Within 30 days after administration)
- Assessment of Onset of Neuromuscular Blockade(Within 1 day after administration)
- Assessment of Neuromuscular Recovery(Within 1 day after administration)
