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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1
Awake is defined as the patient being awake with electrical brain stimulation mapping during the critical portions of the procedure.
Non-awake is general anesthesia as per convention with intubation.
Mayo Clinic in Florida
Jacksonville, Florida, United States
Extent of resection
Extent of resection (EOR) defined as the residual volume, in cm3, of tumor measured by MRI
Time frame: up to 48 hrs post operation
Percentage of baseline tumor volume resected
Measured by MRI
Time frame: up to 48 hrs post operation
VAS Postoperative anxiety
Postoperative Anxiety scale measured using a 0 to 10 visual analog scale (0: no anxiety, 10: worst anxiety)
Time frame: Day 1(+14 days) , Post op day 0, 1, 2 weeks, 3mth
Length of Surgery
defined as time entering OR and leaving OR
Time frame: Intraoperative
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