Awake vs. Asleep Craniotomy for Non-eloquent Gliomas
Randomized Control Trial for Awake vs. Asleep Craniotomy for Non-eloquent Gliomas
1 other identifier
interventional
1
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2018
CompletedFirst Posted
Study publicly available on registry
August 8, 2018
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2023
CompletedMay 26, 2023
May 1, 2023
4 years
August 2, 2018
May 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Extent of resection
Extent of resection (EOR) defined as the residual volume, in cm3, of tumor measured by MRI
up to 48 hrs post operation
Secondary Outcomes (3)
Percentage of baseline tumor volume resected
up to 48 hrs post operation
VAS Postoperative anxiety
Day 1(+14 days) , Post op day 0, 1, 2 weeks, 3mth
Length of Surgery
Intraoperative
Other Outcomes (5)
Length of hospital stay (LOS)
0-30 days post operation
The Karnofsky Performance Score
Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths
FACT-Br
Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths
- +2 more other outcomes
Study Arms (2)
Non-Awake Cohort
ACTIVE COMPARATORCohort undergoing craniotomy utilizing general anesthesia protocol
Awake Cohort
EXPERIMENTALCohort undergoing craniotomy utilizing awake anesthesia protocol
Interventions
Awake is defined as the patient being awake with electrical brain stimulation mapping during the critical portions of the procedure.
Non-awake is general anesthesia as per convention with intubation.
Eligibility Criteria
You may qualify if:
- Patients with age ≥18 years old.
- WHO grade I, II, III, and IV Glioma in non-eloquent brain cortex based on magnetic resonance imaging (MRI)
- An elective procedure.
- A single lesion.
- No major comorbidities that would necessitate an extended hospital stay.
- Newly diagnosed tumors.
You may not qualify if:
- Patients with age \< 18 years old.
- Non-gliomas
- Eloquent location (motor, sensory, language)
- Non-elective procedure.
- Multiple lesions.
- Major comorbidities.
- Recurrent tumors.
- Patients lacking capacity to consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Kaisorn L Chaichana
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Associate Consultant
Study Record Dates
First Submitted
August 2, 2018
First Posted
August 8, 2018
Study Start
June 1, 2019
Primary Completion
May 21, 2023
Study Completion
May 21, 2023
Last Updated
May 26, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share