Awake vs. Asleep Craniotomy for Non-eloquent Gliomas
Status: | Not yet recruiting |
---|---|
Conditions: | Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/27/2019 |
Start Date: | March 2019 |
End Date: | March 2020 |
Randomized Control Trial for Awake vs. Asleep Craniotomy for Non-eloquent Gliomas
This study protocol examines a comparison between local and general anesthesia (Awake vs.
Asleep Craniotomy) in the removal of brain tumors that are in areas of the brain that do not
directly control bodily functions (non-eloquent gliomas).
Asleep Craniotomy) in the removal of brain tumors that are in areas of the brain that do not
directly control bodily functions (non-eloquent gliomas).
This is a single-center, prospective randomized open or non-blinded end-point (PROBE)
clinical trial. Patients will be selected by the neurosurgeon according to the inclusion and
exclusion criteria. Patients who consent to randomization will have confirmed non-eloquent
status confirmed by independent surgeon and will be randomized into 1 of 2 treatment groups
utilizing a dynamic minimization approach. The experimental group with randomization of
patients who will undergo awake craniotomy for both high and low grade gliomas in
non-eloquent areas or a control group of patients who will have asleep craniotomy for both
high and low grade gliomas in non-eloquent regions.
clinical trial. Patients will be selected by the neurosurgeon according to the inclusion and
exclusion criteria. Patients who consent to randomization will have confirmed non-eloquent
status confirmed by independent surgeon and will be randomized into 1 of 2 treatment groups
utilizing a dynamic minimization approach. The experimental group with randomization of
patients who will undergo awake craniotomy for both high and low grade gliomas in
non-eloquent areas or a control group of patients who will have asleep craniotomy for both
high and low grade gliomas in non-eloquent regions.
INCLUSION CRITERIA
1. Patients with age ≥18 years old.
2. WHO grade I, II, III, and IV Glioma in non-eloquent brain cortex based on magnetic
resonance imaging (MRI)
3. An elective procedure.
4. A single lesion.
5. No major comorbidities that would necessitate an extended hospital stay.
6. Newly diagnosed tumors.
EXCLUSION CRITERIA
1. Patients with age < 18 years old.
2. Non-gliomas
3. Eloquent location (motor, sensory, language)
4. Non-elective procedure.
5. Multiple lesions.
6. Major comorbidities.
7. Recurrent tumors.
8. Patients lacking capacity to consent.
We found this trial at
3
sites
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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