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临床试验/NCT02439164
NCT02439164已完成不适用

Cohort Study of Sedatives' Effects on Neurological Function in Patients With Eloquent Area Glioma: Comparison With a Control Group Without Intracranial Pathology

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2015年5月26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
36
试验地点
1
主要终点
Task Completing Time Change Between Sedation and Baseline Measured by 9-hole Peg Test

研究概览

简要总结

Sedation in the operating room, the Post Anesthesia Care Unit and the Intensive Care Unit is common and often necessary for patients with intracranial brain tumor. Repeated neurological function assessments is needed in those locations, especially in patients with tumors in or near eloquent regions, this is to monitor their neurologic performance to determine if there are alterations that require treatment. Some slowly infiltrative low-grade gliomas near eloquent regions do not show any detectable neurologic deficits, perhaps from reorganization, but with sedation by some sedatives such as benzodiazepine midazolam and anesthetic hypnotic propofol, the disease may seem much worse resulting in inappropriately aggressive treatment. This may be especially problematic in patients undergoing awake craniotomy for tumors in eloquent regions.

This is a single-center perspective study. Patients will be mildly sedated to keep them responsive and cooperative. Motor and sensory function will be evaluated before and after mild sedation. Specific benzodiazepine antagonist will be used if sedated by midazolam.

The purpose of this study is to observe if commonly used benzodiazepine midazolam exacerbates or unmasks motor and sensory function in patients with intracranial eloquent area gliomas.

Hypothesis:

mild sedation can unmasks or exacerbate motor and sensory deficits in patients with eloquent area glioma but not in non-neurosurgical patients/healthy volunteers. If the neurologic deficits induced by benzodiazepine agonist, then can be reversed by flumazenil.

研究设计

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

  • Age between 18-60 year-old
  • American Society of Anesthesiology(ASA) status I~II
  • Elective craniotomy patients with supratentorial eloquent glioma diagnosed by MRI (In control group: volunteers without neuro-diseases)

排除标准

  • Unable to comprehend and cooperate with the neurologic examination
  • Impaired mental status
  • Taking sedative drugs in the past 24 hours
  • Taking pain reliever in the past 24 hours
  • Drug and/or alcohol abuse
  • Pregnant and/o lactating women
  • Recurrent brain tumors
  • Multiple brain tumors
  • Accepting radiotherapy or chemotherapy
  • Complicated with intracranial trauma and vascular diseases
  • Complicated with grand mal epilepsy ( in midazolam group)
  • Complicated with neuromuscular diseases
  • Complicated with cutaneous paresthesia

研究组 & 干预措施

Glioma group

Experimental

Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.

干预措施: Midazolam (Drug)

non-neurosurgical group

Active Comparator

patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.

干预措施: Midazolam (Drug)

结局指标

主要结局

Task Completing Time Change Between Sedation and Baseline Measured by 9-hole Peg Test

时间窗: after sedation

this is a focal neurologic deficits induced by sedatives, the outcome is the performing time changes after sedation as : sedation-baseline.

次要结局

  • Number of Participants With OAA/S=4 After Sedation(withing 1 hour)
  • Mean Arterial Blood Pressure (MAP) as a Measure of Physiological Change(1 hour)
  • Heart Rate as a Measure of Physiological Change(1 hour)
  • Brain Glioma Pathological Diagnose as a Measure of Tumor Type(2 weeks)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nan Lin

M.D.

Beijing Tiantan Hospital

研究点 (1)

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