Spots Global Cancer Trial Database for Awake vs. Asleep Craniotomy for Non-eloquent Gliomas

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Trial Identification

Brief Title: Awake vs. Asleep Craniotomy for Non-eloquent Gliomas

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

Study ID: NCT03621748

Conditions

Intracranial Glioma

Interventions

Awake Anesthesia Protocol

Non-awake Anesthesia Protocol

Study Description

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.