Intracranial Glioma
Conditions
Keywords
craniotomy, awake craniotomy
Brief summary
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).
Detailed 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.
Interventions
PROCEDUREAwake Anesthesia Protocol
Awake is defined as the patient being awake with electrical brain stimulation mapping during the critical portions of the procedure.
PROCEDURENon-awake Anesthesia Protocol
Non-awake is general anesthesia as per convention with intubation.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extent of resection | up to 48 hrs post operation | Extent of resection (EOR) defined as the residual volume, in cm3, of tumor measured by MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of baseline tumor volume resected | up to 48 hrs post operation | Measured by MRI |
| VAS Postoperative anxiety | Day 1(+14 days) , Post op day 0, 1, 2 weeks, 3mth | Postoperative Anxiety scale measured using a 0 to 10 visual analog scale (0: no anxiety, 10: worst anxiety) |
| Length of Surgery | Intraoperative | defined as time entering OR and leaving OR |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay (LOS) | 0-30 days post operation | admission to discharge |
| Cost of treatment | captured until 30 days post operation | Analysis to include standardized cost, physician service cost, cost of hospitalization and 30 days post-hospitalization cost |
| The Karnofsky Performance Score | Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths | (KPS) ranking runs from 100 to 0, where 100 is perfect health and 0 is death |
| FACT-Br | Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths | The FACT-Brain (FACT-Br) provides an additional set of disease-specific questions pertaining to brain neoplasms |
| Post-operative pain scale | Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths | 0 to 10 (0: No pain, 10: Worst pain) - Numeric Scale |
Countries
United States
Outcome results
None listed