Glioma, Malignant, Gliomas Benign, Metastases to Brain
Conditions
Keywords
contrast-enhancing glioma, non-enhancing glioma, brain metastasis, awake surgery, general anesthesia, motor area
Brief 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.
Interventions
PROCEDURETumor resection in awake patient
Surgeon performs critical steps of tumor removal in awake patient and controls his/her motor functions by brain mapping and assessing of voluntary movements
PROCEDURETumor resection in asleep patient
Surgeon removes tumor in asleep patient and controls his/her motor functions by brain mapping
Sponsors
Sklifosovsky Institute of Emergency Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite event of deterioration of early motor function, severe disturbance of consciousness or death from any cause | within 10 days after surgery | Motor function is assessed in Medical Research Council scale and is compared before and after surgery, deterioration of motor function means decline of 1 grade or more; level of consciousness is assessed in Glasgow Coma scale, it's severe disturbance means decline to 9 points or less |
| Dynamics of early motor function (in grades) | within 10 days after surgery | Early motor function is assessed in Medical Research Council scale and is compared before and after surgery |
| Dynamics of late motor function (in grades) | in 3 months after surgery | Late motor function is assessed in Medical Research Council scale and is compared before and in 3 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early Karnofsky performance status (in percents) | within 10 days after surgery | Assesses patients' possibilities to self-service in Karnofsky Performance Status scale |
| Extent of resection (in percents) | within 48 hours after surgery | Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100 |
| Gross total resection (Yes or No) | within 48 hours after surgery | Absence of tumor tissue in postoperative magnetic resonance imaging |
| Duration of surgery (in minutes) | Intraoperatively | Duration of surgery from skin incision till last skin suture |
| Intraoperative blood loss (in milliliters) | Intraoperatively | Blood loss from skin incision till last skin suture |
| Late speech function (in grades) | in 3 months after surgery | Late speech function is assessed in Hendrix scale (2017) |
| Duration of hospital stay (in days) | From admission to the hospital till hospital discharge, up to 365 days | How long patient was treated in the hospital from admission till discharge |
| Cerebral complications | within 3 months after surgery | Which cerebral complications arose after surgery |
| Somatic complications | From admission to intensive care unit after surgery till hospital discharge, up to 365 days | Which somatic disorders arose after surgery |
| Repeated hospital admission (Yes or No) | within 3 months after surgery | Whether repeated hospital admissions were required due to postoperative complications |
| Late Karnofsky performance status (in percents) | in 3 months after surgery | Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale |
| Duration of stay in intensive care unit (in days) | From admission to intensive care unit after surgery till transfer to neurosurgical unit, up to 365 days | How long patient was treated in intensive care unit |
| Composite event of deterioration of early speech, severe disturbance of consciousness or death from any cause | within 10 days after surgery | Speech function is assessed in Hendrix scale (2017) and is compared before and after surgery, deterioration of speech function means decline of 1 grade or more; level of consciousness is assessed in Glasgow Coma scale, it's severe depressing means decline to 9 points or less |
| Early speech function (in grades) | within 10 days after surgery | Early speech function is assessed in Hendrix scale (2017) |
Countries
Russia
Outcome results
None listed