SuspendedNot Applicable

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

Stopped: technical issues

Russia72 participantsStarted 2022-09-01

Plain-language 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.

Who can participate

Age range

18 Years – 69 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite event of deterioration of early motor function, severe disturbance of consciousness or death from any cause

Timeframe: within 10 days after surgery

Dynamics of early motor function (in grades)

Timeframe: within 10 days after surgery

Dynamics of late motor function (in grades)

Timeframe: in 3 months after surgery

Trial details

NCT IDNCT05485038

SponsorSklifosovsky Institute of Emergency Care

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2027-08-31

View on ClinicalTrials.gov More Gliomas Benign trials

Who can participate

Age range

18 Years – 69 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Composite event of deterioration of early motor function, severe disturbance of consciousness or death from any cause

Timeframe: within 10 days after surgery

Dynamics of early motor function (in grades)

Timeframe: within 10 days after surgery

Dynamics of late motor function (in grades)

Timeframe: in 3 months after surgery