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临床试验/NCT01885715
NCT01885715已完成不适用

Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
1
主要终点
time to reverse from light muscle relaxation

研究概览

简要总结

This study aims to find appropriate dose of neostigmine which is possible to reverse rocuronium or cisatracurium till train of four (TOF) 0.9 within 10 minutes.

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
Single (Outcomes Assessor)

入排标准

年龄范围
19 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologist Physical status classification 1 or 2 elective surgery under general anesthesia

排除标准

  • BMI >25 or < 20 kg/m2
  • Patients taking intercurrent medication
  • Glutamic Oxalacetate Transaminase or Glutamic Pyruvate Transaminase > 40 IU/L, Cr > 1.4 mg/dl

研究组 & 干预措施

Rocuronium-placebo

Placebo Comparator

At anesthetic induction, rocuronium 0.6 mg/kg will be injected for muscle relaxation.

During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. When TOF ratio recover to 0.5, normal saline 5 ml will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0

干预措施: Injection of neostigmine (Drug)

Rocuronium-neostigmine 10 ㎍

Active Comparator

At anesthetic induction, rocuronium 0.6 mg/kg will be injected for muscle relaxation.

During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 10 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0.

干预措施: Injection of neostigmine (Drug)

Rocuronium-neostigmine 20 ㎍

Active Comparator

At anesthetic induction, rocuronium 0.6 mg/kg will be injected for muscle relaxation.

During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 20 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0

干预措施: Injection of neostigmine (Drug)

Rocuronium-neostigmine 40 ㎍

Active Comparator

At anesthetic induction, rocuronium 0.6 mg/kg will be injected for muscle relaxation.

During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 40 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0

干预措施: Injection of neostigmine (Drug)

Cisatracurium-placebo

Placebo Comparator

At anesthetic induction, cisatracurium 0.15 mg/kg will be injected for muscle relaxation.

During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, normal saline 5 ml will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0

干预措施: Injection of neostigmine (Drug)

Cisatracurium-neostigmine 10 ㎍

Active Comparator

At anesthetic induction, cisatracurium 0.15 mg/kg will be injected for muscle relaxation.

During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 10 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0

干预措施: Injection of neostigmine (Drug)

Cisatracurium-neostigmine 20 ㎍

Active Comparator

At anesthetic induction, cisatracurium 0.15 mg/kg will be injected for muscle relaxation.

During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 20 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0

干预措施: Injection of neostigmine (Drug)

Cisatracurium-neostigmine 40 ㎍

Active Comparator

At anesthetic induction, cisatracurium 0.15 mg/kg will be injected for muscle relaxation.

During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 40 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0

干预措施: Injection of neostigmine (Drug)

结局指标

主要结局

time to reverse from light muscle relaxation

时间窗: time from TOF 0.5 to TOF 1.0 after injection of different doses of neostigmine

Primary outcome of this study is how long it takes time to reverse from TOF ratio 0.5 to 1.0 after injection of different doses of neostigmine at the TOF 0.5

次要结局

  • time to reverse from TOF ratio 0.5 to 0.9(time from TOF 0.5 to TOF 0.9 after injection of different doses of neostigmine)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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