NCT05485038

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

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Sklifosovsky Institute of Emergency Care · Other Government
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gliomas Benign
• Glioma, Malignant
• Metastases to Brain

Interventions

Type	Name	Description
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
PROCEDURE	Tumor resection in asleep patient	Surgeon removes tumor in asleep patient and controls his/her motor functions by brain mapping

Timeline

• Start date: 2022-09-01
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2022-08-02
• Last updated: 2025-05-16

Locations

1 site across 1 country: Russia