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Awake vs. Asleep Craniotomy for Non-eloquent Gliomas

Primary Purpose

Intracranial Glioma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Awake Anesthesia Protocol
Non-awake Anesthesia Protocol
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Glioma focused on measuring craniotomy, awake craniotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non-Awake Cohort

Awake Cohort

Arm Description

Cohort undergoing craniotomy utilizing general anesthesia protocol

Cohort undergoing craniotomy utilizing awake anesthesia protocol

Outcomes

Primary Outcome Measures

Extent of resection
Extent of resection (EOR) defined as the residual volume, in cm3, of tumor measured by MRI

Secondary Outcome Measures

Percentage of baseline tumor volume resected
Measured by MRI
VAS Postoperative anxiety
Postoperative Anxiety scale measured using a 0 to 10 visual analog scale (0: no anxiety, 10: worst anxiety)
Length of Surgery
defined as time entering OR and leaving OR

Full Information

First Posted
August 2, 2018
Last Updated
May 24, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03621748
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 Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
May 21, 2023 (Actual)
Study Completion Date
May 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Glioma
Keywords
craniotomy, awake craniotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Awake Cohort
Arm Type
Active Comparator
Arm Description
Cohort undergoing craniotomy utilizing general anesthesia protocol
Arm Title
Awake Cohort
Arm Type
Experimental
Arm Description
Cohort undergoing craniotomy utilizing awake anesthesia protocol
Intervention Type
Procedure
Intervention Name(s)
Awake Anesthesia Protocol
Intervention Description
Awake is defined as the patient being awake with electrical brain stimulation mapping during the critical portions of the procedure.
Intervention Type
Procedure
Intervention Name(s)
Non-awake Anesthesia Protocol
Intervention Description
Non-awake is general anesthesia as per convention with intubation.
Primary Outcome Measure Information:
Title
Extent of resection
Description
Extent of resection (EOR) defined as the residual volume, in cm3, of tumor measured by MRI
Time Frame
up to 48 hrs post operation
Secondary Outcome Measure Information:
Title
Percentage of baseline tumor volume resected
Description
Measured by MRI
Time Frame
up to 48 hrs post operation
Title
VAS Postoperative anxiety
Description
Postoperative Anxiety scale measured using a 0 to 10 visual analog scale (0: no anxiety, 10: worst anxiety)
Time Frame
Day 1(+14 days) , Post op day 0, 1, 2 weeks, 3mth
Title
Length of Surgery
Description
defined as time entering OR and leaving OR
Time Frame
Intraoperative
Other Pre-specified Outcome Measures:
Title
Length of hospital stay (LOS)
Description
admission to discharge
Time Frame
0-30 days post operation
Title
The Karnofsky Performance Score
Description
(KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death
Time Frame
Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths
Title
FACT-Br
Description
The FACT-Brain (FACT-Br) provides an additional set of disease-specific questions pertaining to brain neoplasms
Time Frame
Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths
Title
Post-operative pain scale
Description
0 to 10 (0: No pain, 10: Worst pain) - Numeric Scale
Time Frame
Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths
Title
Cost of treatment
Description
Analysis to include standardized cost, physician service cost, cost of hospitalization and 30 days post-hospitalization cost
Time Frame
captured until 30 days post operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA 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. EXCLUSION CRITERIA 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaisorn L Chaichana
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Awake vs. Asleep Craniotomy for Non-eloquent Gliomas

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