Clinical trial NCT05485038: General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas
Official title: General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas: a Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Gliomas Benign
Glioma, Malignant
Metastases to Brain
Keywords: contrast-enhancing glioma
non-enhancing glioma
brain metastasis
awake surgery
general anesthesia
motor area
Lead sponsor: Sklifosovsky Institute of Emergency Care
Sponsor class: OTHER_GOV
First posted: 2022-08-02
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Composite event of deterioration of early motor function, severe disturbance of consciousness or death from any cause
timeFrame: within 10 days after surgery
measure: Dynamics of early motor function (in grades)
timeFrame: within 10 days after surgery
measure: Dynamics of late motor function (in grades)
timeFrame: in 3 months after surgery
Secondary outcomes:
measure: Composite event of deterioration of early speech, severe disturbance of consciousness or death from any cause
timeFrame: within 10 days after surgery
measure: Early speech function (in grades)
timeFrame: within 10 days after surgery
measure: Early Karnofsky performance status (in percents)
timeFrame: within 10 days after surgery
measure: Extent of resection (in percents)
timeFrame: within 48 hours after surgery
measure: Gross total resection (Yes or No)
timeFrame: within 48 hours after surgery
measure: Duration of surgery (in minutes)
timeFrame: Intraoperatively
measure: Intraoperative blood loss (in milliliters)
timeFrame: Intraoperatively
measure: Duration of stay in intensive care unit (in days)
timeFrame: From admission to intensive care unit after surgery till transfer to neurosurgical unit, up to 365 days
measure: Duration of hospital stay (in days)
timeFrame: From admission to the hospital till hospital discharge, up to 365 days
measure: Cerebral complications
timeFrame: within 3 months after surgery
measure: Somatic complications
timeFrame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
measure: Repeated hospital admission (Yes or No)
timeFrame: within 3 months after surgery
measure: Late speech function (in grades)
timeFrame: in 3 months after surgery
measure: Late Karnofsky performance status (in percents)
timeFrame: in 3 months after surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sklifosovsky Institute of Emergency Care
Study officials:
affiliation: Sklifosovsky Institute of Emergency Care
name: Alexander Dmitriev, MD
role: PRINCIPAL_INVESTIGATOR
References: