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

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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).

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.

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
4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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Jacksonville, FL
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Scottsdale, AZ
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