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Sedatives' Effects on Neurological Function in Patients With Eloquent Area Glioma

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ClinicalTrials.gov Identifier: NCT02439164
Recruitment Status : Completed
First Posted : May 8, 2015
Results First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Nan Lin, Beijing Tiantan Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Glioma Drug: Midazolam Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Cohort Study of Sedatives' Effects on Neurological Function in Patients With Eloquent Area Glioma: Comparison With a Control Group Without Intracranial Pathology
Actual Study Start Date : May 26, 2015
Actual Primary Completion Date : March 21, 2017
Actual Study Completion Date : March 21, 2017


Arm Intervention/treatment
Experimental: Glioma group
Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.
Drug: Midazolam
specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used

Active Comparator: non-neurosurgical group
patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.
Drug: Midazolam
specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used




Primary Outcome Measures :
  1. Task Completing Time Change Between Sedation and Baseline Measured by 9-hole Peg Test [ Time Frame: after sedation ]
    this is a focal neurologic deficits induced by sedatives, the outcome is the performing time changes after sedation as : sedation-baseline.


Secondary Outcome Measures :
  1. Number of Participants With OAA/S=4 After Sedation [ Time Frame: withing 1 hour ]
    OAA/S is Observer Assessment of Sedation with 5 levels (5 = alert, 4 = lethargic, 3 = aroused by voice, 2 = aroused by shaking, 1 = deep sleep), all participants have to achieve OAA/S=4 after sedation.

  2. Mean Arterial Blood Pressure (MAP) as a Measure of Physiological Change [ Time Frame: 1 hour ]
    The MAP was measured at three time points: baseline, sedation and sedation reversal.

  3. Heart Rate as a Measure of Physiological Change [ Time Frame: 1 hour ]
    The HR was measured at three time points: baseline, sedation and sedation reversal.

  4. Brain Glioma Pathological Diagnose as a Measure of Tumor Type [ Time Frame: 2 weeks ]
    the WHO grade and the type of glioma (WHO glioma grade I~II is regarded as low grade glioma, WHO glioma grade III~IV is regarded as high grade glioma)



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439164


Locations
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China, Beijing
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing, China, 100055
Sponsors and Collaborators
Beijing Tiantan Hospital
  Study Documents (Full-Text)

Documents provided by Nan Lin, Beijing Tiantan Hospital:
Study Protocol  [PDF] April 1, 2016
Statistical Analysis Plan  [PDF] April 1, 2016


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Responsible Party: Nan Lin, M.D., Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT02439164     History of Changes
Other Study ID Numbers: 2014MP06
First Posted: May 8, 2015    Key Record Dates
Results First Posted: August 25, 2017
Last Update Posted: August 25, 2017
Last Verified: July 2017
Keywords provided by Nan Lin, Beijing Tiantan Hospital:
sedation
eloquent area glioma
neurologic function
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Midazolam
Hypnotics and Sedatives
Adjuvants, Anesthesia
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action