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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glioma group | Experimental | Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used |
|
| Measure | Description | Time Frame |
|---|---|---|
| Task Completing Time Change Between Sedation and Baseline Measured by 9-hole Peg Test | this is a focal neurologic deficits induced by sedatives, the outcome is the performing time changes after sedation as : sedation-baseline. | after sedation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With OAA/S=4 After Sedation | 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. | withing 1 hour |
| Mean Arterial Blood Pressure (MAP) as a Measure of Physiological Change |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100055 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Glioma Group | Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation. Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal |
| FG001 | Non-neurosurgical Group | patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation. Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One patient in non-neurosurgical group was dropped out because he reported his carotid disease history after the task testing. In glioma group, pathological diagnosis displayed two with metastasis and one with meningioma, which were excluded during follow-up. There are 15 in the glioma group and 17 in the control group for the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Glioma Group | Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation. Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Task Completing Time Change Between Sedation and Baseline Measured by 9-hole Peg Test | this is a focal neurologic deficits induced by sedatives, the outcome is the performing time changes after sedation as : sedation-baseline. | Posted | Mean | Standard Deviation | seconds | after sedation |
|
1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glioma Group | Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation. Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nan Lin | Beijing Tiantan Hospital | 861067096658 | linnan127@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 1, 2016 | Jun 30, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 1, 2016 | Jun 30, 2017 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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The MAP was measured at three time points: baseline, sedation and sedation reversal. |
| 1 hour |
| Heart Rate as a Measure of Physiological Change | The HR was measured at three time points: baseline, sedation and sedation reversal. | 1 hour |
| Brain Glioma Pathological Diagnose as a Measure of Tumor Type | 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) | 2 weeks |
| Non-neurosurgical Group |
patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation. Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal |
| BG002 | Total | Total of all reporting groups |
| years old |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| weight | Mean | Standard Deviation | kg |
|
| education | Count of Participants | Participants |
|
|
|
|
| Secondary | Number of Participants With OAA/S=4 After Sedation | 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. | Posted | Count of Participants | Participants | withing 1 hour |
|
|
|
| Secondary | Mean Arterial Blood Pressure (MAP) as a Measure of Physiological Change | The MAP was measured at three time points: baseline, sedation and sedation reversal. | Posted | Mean | Standard Deviation | mmHg | 1 hour |
|
|
|
| Secondary | Heart Rate as a Measure of Physiological Change | The HR was measured at three time points: baseline, sedation and sedation reversal. | Posted | Mean | Standard Deviation | bpm | 1 hour |
|
|
|
| Secondary | Brain Glioma Pathological Diagnose as a Measure of Tumor Type | 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) | In non-neurosurgical group, patients were not diagnosed as glioma, so the belowed "outcome measure data table" could not indicate the number of glioma grade. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Non-neurosurgical Group | patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation. Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal | 0 | 17 | 0 | 17 | 0 | 17 |
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D006571 | Heterocyclic Compounds |
| sedation reversal MAP |
|
| sedation reversal |
|