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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gliomas Benign, Glioma, Malignant, Metastases to Brain

Intervention / Treatment
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* Procedure: Tumor resection in awake patient
* Procedure: Tumor resection in asleep patient


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Awake surgery<br>Critical steps of brain mapping and tumor removal will be performed in awake patient | Procedure: Tumor resection in awake patient<br>* Surgeon performs critical steps of tumor removal in awake patient and controls his/her motor functions by brain mapping and assessing of voluntary movements<br>|
| Active Comparator: General anesthesia<br>Brain mapping and tumor removal will be performed in asleep patient | Procedure: Tumor resection in asleep patient<br>* Surgeon removes tumor in asleep patient and controls his/her motor functions by brain mapping<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contrast-enhancing glioma, non-enhancing glioma, brain metastasis, awake surgery, general anesthesia, motor area