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Completed

NCT Number: NCT03621748

Awake vs. Asleep Craniotomy for Non-eloquent Gliomas

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).

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Key information

Conditions

Intracranial Glioma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Awake Anesthesia Protocol

Procedure

Awake is defined as the patient being awake with electrical brain stimulation mapping during the critical portions of the procedure.

Non-awake Anesthesia Protocol

Procedure

Non-awake is general anesthesia as per convention with intubation.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Randomized Control Trial for Awake vs. Asleep Craniotomy for Non-eloquent Gliomas

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2018
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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