Awake vs. Asleep Craniotomy for Non-eloquent Gliomas

Intracranial Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03621748
• Other study ID #: 18-005248
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: May 21, 2023

Study information

• Verified date: May 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 21, 2023
• Est. primary completion date: May 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioma
• Intracranial Glioma

Intervention

Procedure:
• Awake Anesthesia Protocol
Awake is defined as the patient being awake with electrical brain stimulation mapping during the critical portions of the procedure.
• Non-awake Anesthesia Protocol
Non-awake is general anesthesia as per convention with intubation.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay (LOS)	admission to discharge	0-30 days post operation
Other	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
Other	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
Other	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
Other	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
Primary	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	Percentage of baseline tumor volume resected	Measured by MRI	up to 48 hrs post operation
Secondary	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
Secondary	Length of Surgery	defined as time entering OR and leaving OR	Intraoperative

External Links

•   Mayo Clinic Clinical Trials