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

NCT05485038 | Suspended

• 1 other identifier: 9d
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Gliomas Benign; Glioma, Malignant; Metastases to Brain

Keywords

contrast-enhancing glioma; non-enhancing glioma; brain metastasis; awake surgery; general anesthesia; motor area

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (14)

• Composite event of deterioration of early speech, severe disturbance of consciousness or death from any cause

  within 10 days after surgery

• Early speech function (in grades)

  within 10 days after surgery

• Early Karnofsky performance status (in percents)

  within 10 days after surgery

• Extent of resection (in percents)

  within 48 hours after surgery

• Gross total resection (Yes or No)

  within 48 hours after surgery

Study Arms (2)

Awake surgery

EXPERIMENTAL

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

Procedure: Tumor resection in awake patient

General anesthesia

ACTIVE COMPARATOR

Brain mapping and tumor removal will be performed in asleep patient

Procedure: Tumor resection in asleep patient

Interventions

Tumor resection in awake patient 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

Awake surgery

Tumor resection in asleep patient PROCEDURE

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

General anesthesia

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sklifosovsky Institute of Emergency Care: lead

Study Sites (1)

Sklifosovsky Institute of Emergency Care

Moscow, 129090, Russia

Location

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Alexander Dmitriev, MD

  Sklifosovsky Institute of Emergency Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Dynamics of motor function before, within 10 days after surgery and in 3 months after surgery will be assessed by neurosurgeon blinded for the treatment arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 2, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)