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临床试验/NCT04148534
NCT04148534已完成不适用

Intraoperative Monitoring of Facial Nerve in Patients Undergoing Cerbellopontine Angle Tumer Resection Using Partial Versus no Neuromuscular Block

Muhammad Magdy Gaber1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年11月1日最近更新:
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
发起方
入组人数
40
试验地点
1
主要终点
End to start facial nerve MEP amplitude ratio.

研究概览

简要总结

compare the operating condition of two different levels of muscle relaxation on facial nerve monitoring using transcranial motor evocked potential in CPA surgery .

  • To Estimate End to start facial nerve MEP amplitude ratio
  • To determine the effect of neuromuscular relaxant degrees on recovery and
  • Assessment of propofol doses needed for enhancement of early recovery and ambulation.

详细描述

40 Patients aged from 18-60 years old undergoing Cerebellopontine angle surgery. Patients will be one of two groups: Both Induction will be accomplished with fentanyl, propofol , rocronium infusion will be given randomly to one of the groups.

Depth of anaesthesia, neurotransmitter monitoring and facial nerve neurophysiological monitoring will be done.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age between >18 and<
  • Patients scheduled for neurosurgical CPA surgeries
  • Ability to sign the consent
  • ASA classification I, II

排除标准

  • ASA > II
  • Hemodynamically unstable
  • Disease affecting neuromuscular transmission (myasthenia gravies ...etc.)
  • Any cardiac patient (ischemic heart disease - cardiomyopathy...etc.)

研究组 & 干预措施

muscle relaxant

Active Comparator

patient who will receive muscle relaxant, patients will receive rocronium infusion by (5 mcg/kg/min) , maintain partial NMB TOF count 2 and targeting BIS = (40-60)

干预措施: Rocroniom, Non Depolarizing Muscle Relaxant (Drug)

without muscle relaxant

Placebo Comparator

patient who will not receive muscle relaxant, will recieve normal saline targeting BIS = 40-60.

干预措施: Rocroniom, Non Depolarizing Muscle Relaxant (Drug)

结局指标

主要结局

End to start facial nerve MEP amplitude ratio.

时间窗: 6 to 8 month

TCMEP recording will begin (1) prior to skin incision as baseline amplitude before muscle relaxant be taken for intubation (2) at Dural closure and end \\start amplitude ratio will be calculated.

次要结局

  • number of hypotension episodes and the use of vasopressors(6 to 8 month)
  • Total volume of propofol and fentanyl infused(6 to 8 month)

研究者

发起方
Muhammad Magdy Gaber
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Muhammad Magdy Gaber

Ass lecturer

Cairo University

研究点 (1)

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