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

Glioma, Malignant Clinical Trial

— GAMMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485038
• Other study ID #: 9d
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: August 31, 2027

Study information

• Verified date: April 2024
• Source: Sklifosovsky Institute of Emergency Care
• Contact: Alexander Dmitriev, MD
• Phone: +7 (916) 423-54-08
• Email: dmitriev[@]neurosklif.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Glioma, Malignant
• Gliomas Benign
• Metastases to Brain
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Sklifosovsky Institute of Emergency Care	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Sklifosovsky Institute of Emergency Care

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite event of deterioration of early motor function, severe disturbance of consciousness or death from any cause	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	within 10 days after surgery
Primary	Dynamics of early motor function (in grades)	Early motor function is assessed in Medical Research Council scale and is compared before and after surgery	within 10 days after surgery
Primary	Dynamics of late motor function (in grades)	Late motor function is assessed in Medical Research Council scale and is compared before and in 3 months after surgery	in 3 months after surgery
Secondary	Composite event of deterioration of early speech, severe disturbance of consciousness or death from any cause	Speech function is assessed in Hendrix scale (2017) and is compared before and after surgery, deterioration of speech function means decline of 1 grade or more; level of consciousness is assessed in Glasgow Coma scale, it's severe depressing means decline to 9 points or less	within 10 days after surgery
Secondary	Early speech function (in grades)	Early speech function is assessed in Hendrix scale (2017)	within 10 days after surgery
Secondary	Early Karnofsky performance status (in percents)	Assesses patients' possibilities to self-service in Karnofsky Performance Status scale	within 10 days after surgery
Secondary	Extent of resection (in percents)	Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100	within 48 hours after surgery
Secondary	Gross total resection (Yes or No)	Absence of tumor tissue in postoperative magnetic resonance imaging	within 48 hours after surgery
Secondary	Duration of surgery (in minutes)	Duration of surgery from skin incision till last skin suture	Intraoperatively
Secondary	Intraoperative blood loss (in milliliters)	Blood loss from skin incision till last skin suture	Intraoperatively
Secondary	Duration of stay in intensive care unit (in days)	How long patient was treated in intensive care unit	From admission to intensive care unit after surgery till transfer to neurosurgical unit, up to 365 days
Secondary	Duration of hospital stay (in days)	How long patient was treated in the hospital from admission till discharge	From admission to the hospital till hospital discharge, up to 365 days
Secondary	Cerebral complications	Which cerebral complications arose after surgery	within 3 months after surgery
Secondary	Somatic complications	Which somatic disorders arose after surgery	From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Secondary	Repeated hospital admission (Yes or No)	Whether repeated hospital admissions were required due to postoperative complications	within 3 months after surgery
Secondary	Late speech function (in grades)	Late speech function is assessed in Hendrix scale (2017)	in 3 months after surgery
Secondary	Late Karnofsky performance status (in percents)	Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale	in 3 months after surgery