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

Sklifosovsky Institute of Emergency Care

Status: Suspended

Conditions: Metastases to Brain; Gliomas Benign; Glioma, Malignant

Treatments: Procedure: Tumor resection in asleep patient; Procedure: Tumor resection in awake patient

Study type: Interventional

Funder types: Other

Identifiers

NCT05485038

9d

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Awake surgery

Experimental group

Description:

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

Treatment:

Procedure: Tumor resection in awake patient

General anesthesia

Active Comparator group

Description:

Brain mapping and tumor removal will be performed in asleep patient

Treatment:

Procedure: Tumor resection in asleep patient