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

General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas: a Randomised, Controlled Trial

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.

Study Overview

• Status: Suspended
• Conditions: Glioma, Malignant; Gliomas Benign; Metastases to Brain
• Intervention / Treatment: Procedure: Tumor resection in awake patient; Procedure: Tumor resection in asleep patient

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 129090
    • Sklifosovsky Institute of Emergency Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Awake surgery; Critical steps of brain mapping and tumor removal will be performed in awake patient	Procedure: 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
Active Comparator: General anesthesia; Brain mapping and tumor removal will be performed in asleep patient	Procedure: Tumor resection in asleep patient; Surgeon removes tumor in asleep patient and controls his/her motor functions by brain mapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	within 10 days after surgery
Early speech function (in grades)	Early speech function is assessed in Hendrix scale (2017)	within 10 days after surgery
Early Karnofsky performance status (in percents)	Assesses patients' possibilities to self-service in Karnofsky Performance Status scale	within 10 days after surgery
Extent of resection (in percents)	Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100	within 48 hours after surgery
Gross total resection (Yes or No)	Absence of tumor tissue in postoperative magnetic resonance imaging	within 48 hours after surgery
Duration of surgery (in minutes)	Duration of surgery from skin incision till last skin suture	Intraoperatively
Intraoperative blood loss (in milliliters)	Blood loss from skin incision till last skin suture	Intraoperatively
Duration of stay in intensive care unit (in days)	How long patient was treated in intensive care unit	From admission to intensive care unit after surgery till transfer to neurosurgical unit, up to 365 days
Duration of hospital stay (in days)	How long patient was treated in the hospital from admission till discharge	From admission to the hospital till hospital discharge, up to 365 days
Cerebral complications	Which cerebral complications arose after surgery	within 3 months after surgery
Somatic complications	Which somatic disorders arose after surgery	From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Repeated hospital admission (Yes or No)	Whether repeated hospital admissions were required due to postoperative complications	within 3 months after surgery
Late speech function (in grades)	Late speech function is assessed in Hendrix scale (2017)	in 3 months after surgery
Late Karnofsky performance status (in percents)	Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale	in 3 months after surgery

Collaborators and Investigators

• Sponsor: Sklifosovsky Institute of Emergency Care
• Investigators: Principal Investigator: Alexander Dmitriev, MD, Sklifosovsky Institute of Emergency Care

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 30, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: general anesthesia; brain metastasis; contrast-enhancing glioma; non-enhancing glioma; awake surgery; motor area
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplastic Processes; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplasm Metastasis; Glioma
• Other Study ID Numbers: 9d

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No