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临床试验/NCT03019835
NCT03019835已完成不适用

Can we Antagonize Mivacurium With Neostigmine

Université Libre de Bruxelles1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年12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
80
试验地点
1
主要终点
Change in TOF ( Train Of Four) measure

研究概览

简要总结

The antagonism of neuromuscular blocking agents (NMBA) (or curares), as well as the antagonism of other drugs used in anesthesia, is a major challenge for the speciality.

Residual paralysis is indeed a risk factor for post-operative morbidity and mortality and antagonization of curares at the end of the procedure is associated with a reduction in mortality .

Its use should be as large as possible and its contraindications are extremely rare.

The antagonism of the NMBA reduces the duration of the neuromuscular block and the complications that are associated .

In this study, the investigators use mivacurium (or Mivacron) as non-depolarizing curare and neostigmine as an antagonist.

Neostigmine reduces the duration of the neuromuscular block induced by mivacurium, By reducing the breakdown of acetylcholine, neostigmine induces an increase in acetylcholine in the synaptic cleft which competes for the same binding site as nondepolarizing neuromuscular blocking agents, and reverses the neuromuscular blockade.

But the use of neostigmine in current practice is not very widespread in this clinical situation.

The reduction in the duration of the block is significant in comparison with a spontaneous recovery .

Moreover, spontaneous recovery is not always complete and sometimes very long.

Nevertheless, its action is effective and this study could support this use but also specify the duration and the quality of the return to normal of the neuromuscular transmission.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

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

入选标准

  • Patients American Society of Anesthesiologists (ASA) 1 to 3
  • Absence of neuromuscular disease, renal and hepatic insufficiency
  • Absence of medication that could interfere with the mediators of the neuromuscular junction

排除标准

  • Bronchial asthma
  • Parkinson disease
  • Known hypersensitivity to neostigmine or to any of the excipients of Neostigmine

研究组 & 干预措施

GROUP 1

Active Comparator

A group receiving neostigmine (40 mcg / kg) when the block Neuromuscular block's recovery measured by acceleromyography is 1 response of 4 in TOF mode (Train Of Four)

干预措施: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery (Drug)

GROUP 2

Active Comparator

A group receiving neostigmine (40 mcg / kg) when the block Neuromuscular block's recovery measured by acceleromyography is 2 response of 4 in TOF mode (Train Of Four)

干预措施: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery (Drug)

GROUP 3

Active Comparator

A group receiving neostigmine (40 mcg / kg) when the block Neuromuscular block's recovery measured by acceleromyography is 3 response of 4 in TOF mode (Train Of Four)

干预措施: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery (Drug)

GROUP 4

Active Comparator

A group receiving neostigmine (40 mcg / kg) when the block Neuromuscular block's recovery measured by acceleromyography is 4 response of 4 in TOF mode (Train Of Four)

干预措施: Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery (Drug)

CONTROL

Active Comparator

A control group : not receiving an antagonist (spontaneous recovery)

干预措施: Spontaneous recovery (Other)

结局指标

主要结局

Change in TOF ( Train Of Four) measure

时间窗: for each patient, measure of Train Of Four at 3, 6, 9, 12, 15 minutes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JOHN NICOLARDOT

MD

Université Libre de Bruxelles

研究点 (1)

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