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

Sponsor

Sklifosovsky Institute of Emergency Care (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05485038

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gliomas Benign Glioma, Malignant Metastases to Brain	Procedure: Tumor resection in awake patient Procedure: Tumor resection in asleep patient	N/A

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.

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

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Dynamics of motor function before and after surgery will be assessed by neurologists blinded for the treatment arm

Primary Purpose:

Treatment

Official Title:

General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas: a Randomised, Controlled Trial

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2027

Anticipated Study Completion Date :

Aug 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Awake surgery Critical steps of brain mapping and tumor removal will be performed in awake patient	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
Active Comparator: General anesthesia Brain mapping and tumor removal will be performed in asleep patient	Procedure: Tumor resection in asleep patient Surgeon removes tumor in asleep patient and controls his/her motor functions by brain mapping

Arm

Intervention/Treatment

Experimental: Awake surgery

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

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

Active Comparator: General anesthesia

Brain mapping and tumor removal will be performed in asleep patient

Procedure: Tumor resection in asleep patient

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

Outcome Measures

Primary Outcome Measures

Dynamics of paresis (improving, stable, deterioration) [within 10 days after surgery]
Dynamics of motor function before and after surgery in Medical Research Council scale

Secondary Outcome Measures

Dynamics of aphasia (improving, stable, deterioration) [within 10 days after surgery]
Dynamics of speech disturbances before and after surgery in Bilingual Aphasia Screening Test (Russian version)

Other Outcome Measures

Karnofsky performance status (in percents) [within 10 days after surgery]
Assesses patients' possibilities to self-service in Karnofsky Performance Status scale
Extent of resection (in percents) [within 48 hours after surgery]
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Gross total resection (Yes or No) [within 48 hours after surgery]
Absence of tumor tissue in postoperative magnetic resonance imaging
Duration of surgery (in minutes) [Intraoperatively]
Duration of surgery from skin incision till last skin suture
Intraoperative blood loss (in milliliters) [Intraoperatively]
Blood loss from skin incision till last skin suture
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]
How long patient was treated in intensive care unit
Duration of hospital stay (in days) [From admission to the hospital till hospital discharge, up to 365 days]
How long patient was treated in the hospital from admission till discharge
Somatic complications [From admission to intensive care unit after surgery till hospital discharge, up to 365 days]
Which somatic disorders arose after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 in motor areas
newly diagnosed
Karnofsky Performance Status 60-100%
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)