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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Awake surgery | Experimental | Critical steps of brain mapping and tumor removal will be performed in awake patient |
|
| General anesthesia | Active Comparator | Brain mapping and tumor removal will be performed in asleep patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor resection in awake patient | Procedure | Surgeon performs critical steps of tumor removal in awake patient and controls his/her motor functions by brain mapping and assessing of voluntary movements |
| Measure | Description | Time Frame |
|---|---|---|
| Composite event of deterioration of early motor function, severe disturbance of consciousness or death from any cause | 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 | within 10 days after surgery |
| Dynamics of early motor function (in grades) | Early motor function is assessed in Medical Research Council scale and is compared before and after surgery | within 10 days after surgery |
| Dynamics of late motor function (in grades) | Late motor function is assessed in Medical Research Council scale and is compared before and in 3 months after surgery | in 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Composite event of deterioration of early speech, severe disturbance of consciousness or death from any cause | 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 | within 10 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Dmitriev, MD | Sklifosovsky Institute of Emergency Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sklifosovsky Institute of Emergency Care | Moscow | 129090 | Russia |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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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
| Tumor resection in asleep patient | Procedure | Surgeon removes tumor in asleep patient and controls his/her motor functions by brain mapping |
|
| Early speech function (in grades) | Early speech function is assessed in Hendrix scale (2017) | within 10 days after surgery |
| Early Karnofsky performance status (in percents) | Assesses patients' possibilities to self-service in Karnofsky Performance Status scale | within 10 days after surgery |
| Extent of resection (in percents) | Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100 | within 48 hours after surgery |
| Gross total resection (Yes or No) | Absence of tumor tissue in postoperative magnetic resonance imaging | within 48 hours after surgery |
| Duration of surgery (in minutes) | Duration of surgery from skin incision till last skin suture | Intraoperatively |
| Intraoperative blood loss (in milliliters) | Blood loss from skin incision till last skin suture | Intraoperatively |
| Duration of stay in intensive care unit (in days) | How long patient was treated in intensive care unit | From admission to intensive care unit after surgery till transfer to neurosurgical unit, up to 365 days |
| Duration of hospital stay (in days) | How long patient was treated in the hospital from admission till discharge | From admission to the hospital till hospital discharge, up to 365 days |
| Cerebral complications | Which cerebral complications arose after surgery | within 3 months after surgery |
| Somatic complications | Which somatic disorders arose after surgery | From admission to intensive care unit after surgery till hospital discharge, up to 365 days |
| Repeated hospital admission (Yes or No) | Whether repeated hospital admissions were required due to postoperative complications | within 3 months after surgery |
| Late speech function (in grades) | Late speech function is assessed in Hendrix scale (2017) | in 3 months after surgery |
| Late Karnofsky performance status (in percents) | Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale | in 3 months after surgery |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |