Clinical trial · Interventional
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
NCT05485038CI-TRIAL-00089783GAMMAsuspendedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): technical issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma, Malignant | Malignant Glioma | ALIAS | 0.90 |
| Gliomas Benign | — | UNRESOLVED | — |
| Metastases to Brain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor resection in asleep patient | Procedure | — | UNRESOLVED |
| Tumor resection in awake patient | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Awake surgery
- description
- Critical steps of brain mapping and tumor removal will be performed in awake patient
- interventionNames
- Procedure: Tumor resection in awake patient
- type
- ACTIVE_COMPARATOR
- label
- General anesthesia
- description
- Brain mapping and tumor removal will be performed in asleep patient
- interventionNames
- Procedure: Tumor resection in asleep patient
Primary outcomes (3)
- measure
- Composite event of deterioration of early motor function, severe disturbance of consciousness or death from any cause
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.