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临床试验/NCT04968054
NCT04968054已完成不适用

Comparison of Intraoperative Neurophysiological Monitoring According to the Use of Anesthetics During Total Intravenous Anesthesia in Spine Surgery Patients

Gangnam Severance Hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年7月20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
入组人数
66
试验地点
1
主要终点
Latency of SSEPs

研究概览

简要总结

Inhalation anesthetics significantly can delay latency and reduce amplitude of cortical MEPs and SSEPs signals compared to intravenous anesthetics by acting on not only GABA (γ-aminobutyric acid) receptors but also NMDA (N-methyl-D-aspartate) receptors, so total intravenous anesthesia (TIVA) have been more preferred for neurophysiological monitoring follow-up during surgery. However, just less than inhalation anesthetics, the decrease of amplitude and the delay of latency also occur according to the dose dependant of propofol. Moreover, it can cause various adverse effects such as delayed recovery after anesthesia or propofol infusion syndrome, consequently, combined methods with other agents or conversion to other relative anesthetics are being made. Remimazolam is a ultra-short-acting benzodiazepine, and unlike conventional benzodiazepine drugs, it is rapidly metabolized in plasma and not accumulates in the body for long periods of infusion or even with high dose administration. Recently, there have been repored that continuous infusion of 0.5-1.5 mg/kg of remimazolam has little effect on the motor evoked potential (MEPs) of cervical spine surgery patients, but this is a case report without the control group; further prospective studies are definitely needed. Therefore, in the case of using propofol or remimazolam for total intravenous anesthesia, we aim to investigate which intravenous anesthetic is more appropriate for intraoperative neurophysiological monitoring by comparing the results of the somatosensory evoked potential (SSEPs) and MEPs according to these anesthetics.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients who aged 20-70 years with ASA-PS 1-3, diagnosed of ossification of the posterior longitudinal ligament or cervical spondylotic myelopathy, in need of intraoperative neurophysiological monitoring

排除标准

  • Tolerance or hypersensitivity to benzodiazepine or propofol
  • Dependence or addiction to psychotropic drugs or alcohol
  • Previous brain-related neurosurgery
  • Inserted status of pacemaker
  • Inserted status of intracranial device
  • Steroids use during surgery
  • Pregnant women, subjects who lack the ability to make decisions and susceptible to voluntary participation decisions

研究组 & 干预措施

Propofol group

Active Comparator

Propofol group will be inducted and maintained total intravenous anesthesia with propofol 2% and remifentanil under Shinider and Minto target controlled infusion (TCI) model, respevtively

干预措施: Arm I (Propofol) (Drug)

Remimazolam group

Experimental

Remimazolam group will be started total intravenous anesthesia with remiamazolam at 6 mg/kg/h at the time of anesthesia induction, and maintained at 0.5-1.5 mg/kg/h.

干预措施: Arm II (Remimazolam) (Drug)

结局指标

主要结局

Latency of SSEPs

时间窗: At the 30 minutes after anesthetic induction (before surgical incision)

The difference of SSEPs between the two groups (propofol vs. remimazolam) compared with baseline SSEPs

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

Dong Woo Han

Professor

Gangnam Severance Hospital

研究点 (1)

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