Clinical trial · Interventional
Awake vs. Asleep Craniotomy for Non-eloquent Gliomas
Randomized Control Trial for Awake vs. Asleep Craniotomy for Non-eloquent Gliomas
NCT03621748CI-TRIAL-00066732completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study protocol examines a comparison between local and general anesthesia (Awake vs. Asleep Craniotomy) in the removal of brain tumors that are in areas of the brain that do not directly control bodily functions (non-eloquent gliomas).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intracranial Glioma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Awake Anesthesia Protocol | Procedure | — | UNRESOLVED |
| Non-awake Anesthesia Protocol | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Non-Awake Cohort
- description
- Cohort undergoing craniotomy utilizing general anesthesia protocol
- interventionNames
- Procedure: Non-awake Anesthesia Protocol
- type
- EXPERIMENTAL
- label
- Awake Cohort
- description
- Cohort undergoing craniotomy utilizing awake anesthesia protocol
- interventionNames
- Procedure: Awake Anesthesia Protocol
Primary outcomes (1)
- measure
- Extent of resection
- timeFrame
- up to 48 hrs post operation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA 1. Patients with age ≥18 years old. 2. WHO grade I, II, III, and IV Glioma in non-eloquent brain cortex based on magnetic resonance imaging (MRI) 3. An elective procedure. 4. A single lesion. 5. No major comorbidities that would necessitate an extended hospital stay. 6. Newly diagnosed tumors. EXCLUSION CRITERIA 1. Patients with age \< 18 years old. 2. Non-gliomas 3. Eloquent location (motor, sensory, language) 4. Non-elective procedure. 5. Multiple lesions. 6. Major comorbidities. 7. Recurrent tumors. 8. Patients lacking capacity to consent.
References
Publications (0)
Data not yet available
No reference posted for this study.