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Awake vs. Asleep Craniotomy for Non-eloquent Gliomas

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ClinicalTrials.gov Identifier: NCT03621748
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Kaisorn L. Chaichana, Mayo Clinic

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).

Condition or disease Intervention/treatment Phase
Intracranial Glioma Procedure: Awake Anesthesia Protocol Procedure: Non-awake Anesthesia Protocol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Control Trial for Awake vs. Asleep Craniotomy for Non-eloquent Gliomas
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Non-Awake Cohort
Cohort undergoing craniotomy utilizing general anesthesia protocol
Procedure: Non-awake Anesthesia Protocol
Non-awake is general anesthesia as per convention with intubation.

Experimental: Awake Cohort
Cohort undergoing craniotomy utilizing awake anesthesia protocol
Procedure: Awake Anesthesia Protocol
Awake is defined as the patient being awake with electrical brain stimulation mapping during the critical portions of the procedure.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Percentage of baseline tumor volume resected [ Time Frame: up to 48 hrs post operation ]
    Measured by MRI

  2. VAS Postoperative anxiety [ Time Frame: Day 1(+14 days) , Post op day 0, 1, 2 weeks, 3mth ]
    Postoperative Anxiety scale measured using a 0 to 10 visual analog scale (0: no anxiety, 10: worst anxiety)

  3. Length of Surgery [ Time Frame: Intraoperative ]
    defined as time entering OR and leaving OR


Other Outcome Measures:
  1. Length of hospital stay (LOS) [ Time Frame: 0-30 days post operation ]
    admission to discharge

  2. The Karnofsky Performance Score [ Time Frame: Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths ]
    (KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death

  3. FACT-Br [ Time Frame: Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths ]
    The FACT-Brain (FACT-Br) provides an additional set of disease-specific questions pertaining to brain neoplasms

  4. Post-operative pain scale [ Time Frame: Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths ]
    0 to 10 (0: No pain, 10: Worst pain) - Numeric Scale

  5. Cost of treatment [ Time Frame: captured until 30 days post operation ]
    Analysis to include standardized cost, physician service cost, cost of hospitalization and 30 days post-hospitalization cost



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621748


Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Elizabeth Martin    904-953-3844    Martin.Elizabeth1@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Kaisorn L Chaichana Mayo Clinic

Additional Information:
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Responsible Party: Kaisorn L. Chaichana, Senior Associate Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03621748     History of Changes
Other Study ID Numbers: 18-005248
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaisorn L. Chaichana, Mayo Clinic:
craniotomy
awake craniotomy
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs