Awake vs. Asleep Craniotomy for Non-eloquent Gliomas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2023-05-21

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).

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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.

Conditions

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Intracranial Glioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Non-Awake Cohort

Cohort undergoing craniotomy utilizing general anesthesia protocol

Group Type ACTIVE_COMPARATOR

Non-awake Anesthesia Protocol

Intervention Type PROCEDURE

Non-awake is general anesthesia as per convention with intubation.

Awake Cohort

Cohort undergoing craniotomy utilizing awake anesthesia protocol

Group Type EXPERIMENTAL

Awake Anesthesia Protocol

Intervention Type PROCEDURE

Awake is defined as the patient being awake with electrical brain stimulation mapping during the critical portions of the procedure.

Interventions

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Awake Anesthesia Protocol

Awake is defined as the patient being awake with electrical brain stimulation mapping during the critical portions of the procedure.

Intervention Type PROCEDURE

Non-awake Anesthesia Protocol

Non-awake is general anesthesia as per convention with intubation.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No