Neoplasms

Symptoms and General Pathology

All Conditions

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Neoplasm Metastasis

Glioma

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Neoplasms, Neuroepithelial

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Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

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Anesthetics

Critical steps of brain mapping and tumor removal will be performed in awake patient

Brain mapping and tumor removal will be performed in asleep 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

Tumor resection in awake patient

Surgeon removes tumor in asleep patient and controls his/her motor functions by brain mapping

Tumor resection in asleep patient

Alexander Dmitriev, MD

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.

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

General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas

General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas: a Randomised, Controlled Trial

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

Early motor function is assessed in Medical Research Council scale and is compared before and after surgery

Late motor function is assessed in Medical Research Council scale and is compared before and in 3 months 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 is assessed in Hendrix scale (2017)

Assesses patients' possibilities to self-service in Karnofsky Performance Status scale

Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100

Absence of tumor tissue in postoperative magnetic resonance imaging

Duration of surgery from skin incision till last skin suture

Blood loss from skin incision till last skin suture

How long patient was treated in intensive care unit

How long patient was treated in the hospital from admission till discharge

Which cerebral complications arose after surgery

Which somatic disorders arose after surgery

Whether repeated hospital admissions were required due to postoperative complications

Late speech function is assessed in Hendrix scale (2017)

Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas	NCT05485038	Gliomas Benign Glioma, Maligna... Metastases to B...	Tumor resection... Tumor resection...	18 Years - 69 Years	Sklifosovsky Institute of Emergency Care
General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas	NCT05485038	Gliomas Benign Glioma, Maligna... Metastases to B...	Tumor resection... Tumor resection...	18 Years - 69 Years	Sklifosovsky Institute of Emergency Care
General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas	NCT05485038	Gliomas Benign Glioma, Maligna... Metastases to B...	Tumor resection... Tumor resection...	18 Years - 69 Years	Sklifosovsky Institute of Emergency Care

Spots Global Cancer Trial Database for motor area

Every month we try and update this database with for motor area cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for motor area

Every month we try and update this database with for motor area cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for motor area cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.