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

Sklifosovsky Institute of Emergency Care72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gliomas Benign Glioma, Malignant Metastases to Brain

Interventions

Tumor resection in awake patientPROCEDURE

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 asleep patientPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

Sklifosovsky Institute of Emergency Care

Moscow, Russia

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: in 3 months after surgery

Secondary Outcomes

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

Time frame: within 10 days after surgery

Early speech function (in grades)

Early speech function is assessed in Hendrix scale (2017)

Time frame: within 10 days after surgery

Early Karnofsky performance status (in percents)

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.