Awake vs. Asleep Craniotomy for Non-eloquent Gliomas

Randomized Control Trial for 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).

Study Overview

• Status: Completed
• Conditions: Intracranial Glioma
• Intervention / Treatment: Procedure: Non-awake Anesthesia Protocol; Procedure: Awake Anesthesia Protocol

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of baseline tumor volume resected	Measured by MRI	up to 48 hrs post operation
VAS Postoperative anxiety	Postoperative Anxiety scale measured using a 0 to 10 visual analog scale (0: no anxiety, 10: worst anxiety)	Day 1(+14 days) , Post op day 0, 1, 2 weeks, 3mth
Length of Surgery	defined as time entering OR and leaving OR	Intraoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay (LOS)	admission to discharge	0-30 days post operation
The Karnofsky Performance Score	(KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death	Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths
FACT-Br	The FACT-Brain (FACT-Br) provides an additional set of disease-specific questions pertaining to brain neoplasms	Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths
Post-operative pain scale	0 to 10 (0: No pain, 10: Worst pain) - Numeric Scale	Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths
Cost of treatment	Analysis to include standardized cost, physician service cost, cost of hospitalization and 30 days post-hospitalization cost	captured until 30 days post operation

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Kaisorn L Chaichana, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): May 21, 2023
• Study Completion (Actual): May 21, 2023

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: craniotomy; awake craniotomy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 18-005248

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No