Awake vs. Asleep Craniotomy for Non-eloquent Gliomas

Mayo Clinic

Status: Completed

Conditions: Intracranial Glioma

Treatments: Procedure: Non-awake Anesthesia Protocol; Procedure: Awake Anesthesia Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT03621748

18-005248

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups

Non-Awake Cohort

Active Comparator group

Description:

Cohort undergoing craniotomy utilizing general anesthesia protocol

Treatment:

Procedure: Non-awake Anesthesia Protocol

Awake Cohort

Experimental group

Description:

Cohort undergoing craniotomy utilizing awake anesthesia protocol

Treatment:

Procedure: Awake Anesthesia Protocol