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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 69 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05485038
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sklifosovsky Institute of Emergency Care
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alexander Dmitriev, MD
Principal Investigator Affiliation	Sklifosovsky Institute of Emergency Care
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Russian Federation
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Gliomas Benign, Glioma, Malignant, Metastases to Brain

Additional Details

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.

Arms & Interventions

Arms

Experimental: Awake surgery

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

Active Comparator: General anesthesia

Brain mapping and tumor removal will be performed in asleep patient

Interventions

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

Procedure: - Tumor resection in asleep patient

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sklifosovsky Institute of Emergency Care, Moscow, Russian Federation

Status

Recruiting

Address

Sklifosovsky Institute of Emergency Care

Moscow, , 129090

Site Contact

Alexander Dmitriev, MD

[email protected]

+7 (916) 423-54-08

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