Clinical trial NCT03621748: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Glioma
Keywords: craniotomy
awake craniotomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Extent of resection
timeFrame: up to 48 hrs post operation
Secondary outcomes:
measure: Percentage of baseline tumor volume resected
timeFrame: up to 48 hrs post operation
measure: VAS Postoperative anxiety
timeFrame: Day 1(+14 days) , Post op day 0, 1, 2 weeks, 3mth
measure: Length of Surgery
timeFrame: Intraoperative
Other outcomes:
measure: Length of hospital stay (LOS)
timeFrame: 0-30 days post operation
measure: The Karnofsky Performance Score
timeFrame: Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths
measure: FACT-Br
timeFrame: Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths
measure: Post-operative pain scale
timeFrame: Day 1 (+14 days), Post-operative up to 48 hrs, 3-6 weeks, 3mths, 6mths, and 9 mths
measure: Cost of treatment
timeFrame: captured until 30 days post operation
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Kaisorn L Chaichana
role: PRINCIPAL_INVESTIGATOR
References: