Awake vs. Asleep Craniotomy for Non-eloquent Gliomas

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Randomized Control Trial for Awake vs. Asleep Craniotomy for Non-eloquent Gliomas

Conditions
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Intracranial Glioma

Intervention / Treatment
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* Procedure: Awake Anesthesia Protocol
* Procedure: Non-awake Anesthesia Protocol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-Awake Cohort<br>Cohort undergoing craniotomy utilizing general anesthesia protocol | Procedure: Non-awake Anesthesia Protocol<br>* Non-awake is general anesthesia as per convention with intubation.<br>|
| Experimental: Awake Cohort<br>Cohort undergoing craniotomy utilizing awake anesthesia protocol | Procedure: Awake Anesthesia Protocol<br>* Awake is defined as the patient being awake with electrical brain stimulation mapping during the critical portions of the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | Day 1(+14 days) , Post op day 0, 1, 2 weeks, 3mth | 
| Length of Surgery | defined as time entering OR and leaving OR | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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craniotomy, awake craniotomy