Awake vs. Asleep Craniotomy for Non-eloquent Gliomas

  • STATUS
    Recruiting
  • days left to enroll
    67
  • participants needed
    50
  • sponsor
    Mayo Clinic
Updated on 25 January 2021

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).

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.

Details
Condition Intracranial Glioma
Treatment Awake Anesthesia Protocol, Non-awake Anesthesia Protocol
Clinical Study IdentifierNCT03621748
SponsorMayo Clinic
Last Modified on25 January 2021

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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