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

NCT ID: NCT05485038

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2027-08-31

Brief Summary

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

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.

Conditions

Gliomas Benign; Glioma, Malignant; Metastases to Brain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Awake surgery

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

Group Type: EXPERIMENTAL

Tumor resection in awake patient

Intervention Type: PROCEDURE

Surgeon performs critical steps of tumor removal in awake patient and controls his/her motor functions by brain mapping and assessing of voluntary movements

General anesthesia

Brain mapping and tumor removal will be performed in asleep patient

Group Type: ACTIVE_COMPARATOR

Tumor resection in asleep patient

Intervention Type: PROCEDURE

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

Interventions

Tumor resection in awake 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

Intervention Type: PROCEDURE

Tumor resection in asleep patient

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sklifosovsky Institute of Emergency Care

OTHER_GOV

Sponsor Role: lead

Responsible Party

Alexander Dmitriev

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Dmitriev, MD

Role: PRINCIPAL_INVESTIGATOR

Sklifosovsky Institute of Emergency Care

Locations

Sklifosovsky Institute of Emergency Care

Moscow, , Russia

Countries

Russia

Other Identifiers

9d

Identifier Type: -

Identifier Source: org_study_id