Randomized Control Trial for Awake vs. Asleep Craniotomy for Non-eloquent Gliomas
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Extent of resection
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Extent of resection
Time Frame: up to 48 hrs post operation
Extent of resection (EOR) defined as the residual volume, in cm3, of tumor measured by MRI
Secondary Outcomes
- Length of Surgery(Intraoperative)
- VAS Postoperative anxiety(Day 1(+14 days) , Post op day 0, 1, 2 weeks, 3mth)
- Percentage of baseline tumor volume resected(up to 48 hrs post operation)
Investigators
Kaisorn L. Chaichana
Senior Associate Consultant
Mayo Clinic