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临床试验/NCT05687253
NCT05687253已完成2 期

A Phase 2, Randomized, Double-Blind, Active-Controlled, Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery

Baudax Bio1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年10月25日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

BX1000 0.15 mg/kg IV Bolus

干预措施: BX1000 (Drug)

BX1000 0.25 mg/kg

Experimental

BX1000 0.25 mg/kg IV Bolus

干预措施: BX1000 (Drug)

BX1000 0.35 mg/kg

Experimental

BX1000 0.35 mg/kg IV Bolus

干预措施: BX1000 (Drug)

Rocuronium 0.6 mg/kg

Active Comparator

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)

研究者

发起方
Baudax Bio
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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