General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas: a Randomised, Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Sklifosovsky Institute of Emergency Care
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Composite event of deterioration of early motor function, severe disturbance of consciousness or death from any cause
Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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
Eligibility Criteria
- Ages
- 18 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Duration of hospital stay (in days)(From admission to the hospital till hospital discharge, up to 365 days)
- Repeated hospital admission (Yes or No)(within 3 months after surgery)
- 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)
- Duration of surgery (in minutes)(Intraoperatively)
- Cerebral complications(within 3 months after surgery)
- Somatic complications(From admission to intensive care unit after surgery till hospital discharge, up to 365 days)
- Extent of resection (in percents)(within 48 hours after surgery)
- Gross total resection (Yes or No)(within 48 hours after surgery)
- Intraoperative blood loss (in milliliters)(Intraoperatively)
- Duration of stay in intensive care unit (in days)(From admission to intensive care unit after surgery till transfer to neurosurgical unit, up to 365 days)
- Late speech function (in grades)(in 3 months after surgery)
- Late Karnofsky performance status (in percents)(in 3 months after surgery)
Investigators
Alexander Dmitriev
Principal Investigator
Sklifosovsky Institute of Emergency Care