Glioma Clinical Trial
Official title:
Case-cohort Study of Sedatives' Effects on Neurological Function in Patients With Eloquent Area Glioma: Comparison With a Control Group Without Intracranial Pathology
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 case-control 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,
anesthetic hypnotic propofol, and α-2 agonist dexmedetomidine exacerbate or unmask 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.
n/a
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)
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