Gliomas BenignGAMMANCT05485038
General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas
A study testing Tumor resection in awake patient and Tumor resection in asleep patient in people with Gliomas Benign and Glioma, Malignant, run by Sklifosovsky Institute of Emergency Care at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Gliomas Benign, Glioma, Malignant, Metastases to Brain
- What is being tested?
- Tumor resection in awake patient and Tumor resection in asleep patient
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2022to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Show all 13Show fewer
- 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)
Who cannot join
- chronic obstructive pulmonary disease
- persistent smoker (smoking index 11 and more)
- major comorbidities
- implanted pacemaker
- inability to perform intraoperative tests before surgery
- severe aphasia
Show all 12Show fewer
- psychiatric disorders
- barely controlled seizures
- contraindications to magnetic resonance imaging
- previously performed brain radiotherapy
- pregnancy
- breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Tumor resection in awake patient, Tumor resection in asleep patient
- Keywords
- contrast-enhancing glioma, non-enhancing glioma, brain metastasis, awake surgery, general anesthesia, motor area
- Medical subject headings
- Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor resection in awake patientProcedure or surgery
Surgeon performs critical steps of tumor removal in awake patient and controls his/her motor functions by brain mapping and assessing of voluntary movements
Tumor resection in asleep patientProcedure or surgery
Surgeon removes tumor in asleep patient and controls his/her motor functions by brain mapping
| Study group | Role | What they receive |
|---|---|---|
| Awake surgery | Experimental | Critical steps of brain mapping and tumor removal will be performed in awake patient Receives: Procedure: Tumor resection in awake patient |
| General anesthesia | Active comparator | Brain mapping and tumor removal will be performed in asleep patient Receives: Procedure: Tumor resection in asleep patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: in 3 months after surgery
Secondary outcomes (14)
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
Measured: within 10 days after surgery
Early speech function (in grades)
Early speech function is assessed in Hendrix scale (2017)
Measured: within 10 days after surgery
Early Karnofsky performance status (in percents)
Assesses patients' possibilities to self-service in Karnofsky Performance Status scale
Measured: within 10 days after surgery
Extent of resection (in percents)
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Measured: within 48 hours after surgery
Gross total resection (Yes or No)
Absence of tumor tissue in postoperative magnetic resonance imaging
Measured: within 48 hours after surgery
Duration of surgery (in minutes)
Duration of surgery from skin incision till last skin suture
Measured: Intraoperatively
Intraoperative blood loss (in milliliters)
Blood loss from skin incision till last skin suture
Measured: Intraoperatively
Duration of stay in intensive care unit (in days)
How long patient was treated in intensive care unit
Measured: 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
Measured: From admission to the hospital till hospital discharge, up to 365 days
Cerebral complications
Which cerebral complications arose after surgery
Measured: within 3 months after surgery
Somatic complications
Which somatic disorders arose after surgery
Measured: 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
Measured: within 3 months after surgery
Late speech function (in grades)
Late speech function is assessed in Hendrix scale (2017)
Measured: in 3 months after surgery
Late Karnofsky performance status (in percents)
Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale
Measured: in 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Sep 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Why it stopped: technical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gliomas BenignStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sklifosovsky Institute of Emergency Care
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alexander Dmitriev, Sklifosovsky Institute of Emergency Care
- Investigators
- Alexander Dmitriev, MD, Principal investigator, Sklifosovsky Institute of Emergency Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485038
- Sponsor's protocol ID
- 9d
- Acronym
- GAMMA
- Status last verified
- May 2025
- First submitted
- 25 Jul 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas: a Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT05485038
- Acronym / sponsor ID
- GAMMA / 9d
- Conditions
- Gliomas Benign, Glioma, Malignant, Metastases to Brain
- Keywords
- contrast-enhancing glioma, non-enhancing glioma, brain metastasis, awake surgery, general anesthesia, motor area
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: technical issues
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Sklifosovsky Institute of Emergency CareOther government
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Awake surgery | Experimental | Procedure: Tumor resection in awake patientCritical steps of brain mapping and tumor removal will be performed in awake patient |
| General anesthesia | Active comparator | Procedure: Tumor resection in asleep patientBrain mapping and tumor removal will be performed in asleep patient |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (12 listed)
- chronic obstructive pulmonary disease
- persistent smoker (smoking index 11 and more)
- major comorbidities
- implanted pacemaker
- inability to perform intraoperative tests before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor resection in awake patientSurgeon performs critical steps of tumor removal in awake patient and controls his/her motor functions by brain mapping and assessing of voluntary movements | Procedure or surgery | Awake surgery |
| Tumor resection in asleep patientSurgeon removes tumor in asleep patient and controls his/her motor functions by brain mapping | Procedure or surgery | General anesthesia |
Primary outcome
Composite event of deterioration of early motor function, severe disturbance of consciousness or death from any cause
Time frame: within 10 days after surgery
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
Dynamics of early motor function (in grades)
Time frame: within 10 days after surgery
Early motor function is assessed in Medical Research Council scale and is compared before and after surgery
Dynamics of late motor function (in grades)
Time frame: in 3 months after surgery
Late motor function is assessed in Medical Research Council scale and is compared before and in 3 months after surgery
14 secondary outcomes
Composite event of deterioration of early speech, severe disturbance of consciousness or death from any cause
Time frame: within 10 days after surgery
Early speech function (in grades)
Time frame: within 10 days after surgery
Early Karnofsky performance status (in percents)
Time frame: within 10 days after surgery
Extent of resection (in percents)
Time frame: within 48 hours after surgery
Gross total resection (Yes or No)
Time frame: within 48 hours after surgery
Duration of surgery (in minutes)
Time frame: Intraoperatively
Intraoperative blood loss (in milliliters)
Time frame: Intraoperatively
Duration of stay in intensive care unit (in days)
Time frame: From admission to intensive care unit after surgery till transfer to neurosurgical unit, up to 365 days
Duration of hospital stay (in days)
Time frame: From admission to the hospital till hospital discharge, up to 365 days
Cerebral complications
Time frame: within 3 months after surgery
Somatic complications
Time frame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Repeated hospital admission (Yes or No)
Time frame: within 3 months after surgery
Late speech function (in grades)
Time frame: in 3 months after surgery
Late Karnofsky performance status (in percents)
Time frame: in 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Dmitriev, MD principal investigator
Sklifosovsky Institute of Emergency Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor resection in awake patient and Tumor resection in asleep patient in people with Gliomas Benign and Glioma, Malignant, run by Sklifosovsky Institute of Emergency Care at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite event of deterioration of early motor function, severe disturbance of consciousness or death from any cause (time frame: within 10 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.