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Trial Title:
General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas
NCT ID:
NCT05485038
Condition:
Gliomas Benign
Glioma, Malignant
Metastases to Brain
Conditions: Official terms:
Neoplasm Metastasis
Glioma
Conditions: Keywords:
contrast-enhancing glioma
non-enhancing glioma
brain metastasis
awake surgery
general anesthesia
motor area
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Masking description:
Dynamics of motor function before, within 10 days after surgery and in 3 months after
surgery will be assessed by neurosurgeon blinded for the treatment arm
Intervention:
Intervention type:
Procedure
Intervention name:
Tumor resection in awake patient
Description:
Surgeon performs critical steps of tumor removal in awake patient and controls his/her
motor functions by brain mapping and assessing of voluntary movements
Arm group label:
Awake surgery
Intervention type:
Procedure
Intervention name:
Tumor resection in asleep patient
Description:
Surgeon removes tumor in asleep patient and controls his/her motor functions by brain
mapping
Arm group label:
General anesthesia
Summary:
Objective of the study is to determine whether resection of gliomas and metastases of
motor areas using awake surgery can achieve rarer motor deterioration after operation
than using general anesthesia.
Detailed description:
Awake surgery is usually used for tumor resection located in language areas. But
patient's awakening during removal of mass lesions from motor areas can give additional
opportunities. Besides checking of muscle contractions and integrity of motor fibers a
surgeon in awake patient can assess planning of movements, praxis, visual feedback and
vestibular processing of motions. Preserving of voluntary movements can be an additional
proof that cortical motor centers and corticospinal tract were not damaged. At the moment
there are no published results of randomized trials showing advantage of awake surgery in
removal of mass lesions from motor brain areas.
Objective of the study is to determine whether resection of gliomas and metastases of
motor areas using awake surgery can achieve rarer motor deterioration after operation
than using general anesthesia.
Participants of the study will be randomly operated using awake surgery or general
anesthesia. In both groups intraoperative neuromonitoring will be used. Dynamics of motor
functions will be assessed before and after surgery by blinded neurologists.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- single gliomas without contrast enhancement in preoperative magnetic resonance
imaging (presumed low-grade gliomas)
- single gliomas with contrast enhancement in preoperative magnetic resonance imaging
(presumed high-grade gliomas)
- one or several brain metastases from any cancer
- location near primary motor area or corticospinal tract
- newly diagnosed
- Karnofsky Performance Status 60-100%
- muscle strength in assessed limbs 3-5 points in Medical Research Council scale
- age 18-69 years
- body mass index 29 and less
- hemoglobin 110 and more
- platelets 100 and more
- international normalized ratio less than 2,0
- presumed blood loss no more than 8-10 percents of circulating blood volume (no more
than 450-650 milliliters)
Exclusion Criteria:
- chronic obstructive pulmonary disease
- persistent smoker (smoking index 11 and more)
- major comorbidities
- implanted pacemaker
- inability to perform intraoperative tests before surgery
- severe aphasia
- psychiatric disorders
- barely controlled seizures
- contraindications to magnetic resonance imaging
- previously performed brain radiotherapy
- pregnancy
- breast feeding
Gender:
All
Minimum age:
18 Years
Maximum age:
69 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sklifosovsky Institute of Emergency Care
Address:
City:
Moscow
Zip:
129090
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Alexander Dmitriev, MD
Phone:
+7 (916) 423-54-08
Email:
dmitriev@neurosklif.ru
Start date:
September 1, 2022
Completion date:
August 31, 2027
Lead sponsor:
Agency:
Sklifosovsky Institute of Emergency Care
Agency class:
Other
Source:
Sklifosovsky Institute of Emergency Care
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05485038