Overview
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).
Description
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.
Eligibility
INCLUSION CRITERIA
- Patients with age 18 years old.
- WHO grade I, II, III, and IV Glioma in non-eloquent brain cortex based on magnetic resonance imaging (MRI)
- An elective procedure.
- A single lesion.
- No major comorbidities that would necessitate an extended hospital stay.
- Newly diagnosed tumors.
EXCLUSION CRITERIA
- Patients with age < 18 years old.
- Non-gliomas
- Eloquent location (motor, sensory, language)
- Non-elective procedure.
- Multiple lesions.
- Major comorbidities.
- Recurrent tumors.
- Patients lacking capacity to consent.