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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Awake Cohort | Active Comparator | Cohort undergoing craniotomy utilizing general anesthesia protocol |
|
| Awake Cohort | Experimental | Cohort undergoing craniotomy utilizing awake anesthesia protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Awake Anesthesia Protocol | Procedure | Awake is defined as the patient being awake with electrical brain stimulation mapping during the critical portions of the procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Extent of resection | Extent of resection (EOR) defined as the residual volume, in cm3, of tumor measured by MRI | up to 48 hrs post operation |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of baseline tumor volume resected | Measured by MRI | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay (LOS) | admission to discharge | 0-30 days post operation |
| The Karnofsky Performance Score | (KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death |
INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Kaisorn L Chaichana | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Non-awake Anesthesia Protocol | Procedure | Non-awake is general anesthesia as per convention with intubation. |
|
| Day 1(+14 days) , Post op day 0, 1, 2 weeks, 3mth |
| Length of Surgery | defined as time entering OR and leaving OR | Intraoperative |
| Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths |
| FACT-Br | The FACT-Brain (FACT-Br) provides an additional set of disease-specific questions pertaining to brain neoplasms | Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths |
| Post-operative pain scale | 0 to 10 (0: No pain, 10: Worst pain) - Numeric Scale | Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths |
| Cost of treatment | Analysis to include standardized cost, physician service cost, cost of hospitalization and 30 days post-hospitalization cost | captured until 30 days post operation |