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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

Non Recruiting
18-69 years
All
Phase N/A

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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.

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.

Eligibility

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

Study details
    Gliomas Benign
    Glioma
    Malignant
    Metastases to Brain

NCT05485038

Sklifosovsky Institute of Emergency Care

20 August 2025

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