Clinical trial · Interventional
Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy
A Prospective, Single-Blinded, Randomized Study of Awake vs Intubated General Anesthesia in Patients Undergoing Elective Craniotomy for Supratentorial Glioma Resection
- 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 randomized clinical trial studies light sedation compared with intubated general anesthesia (a loss of feeling and a complete loss of awareness that feels like a very deep sleep) in reducing complications and length of hospital stay in patients with brain cancer undergoing craniotomy. Craniotomy is an operation in which a piece of the skull is removed so doctors can remove a brain tumor or abnormal brain tissue. Light sedation allows patients to remain awake during their surgery, while intubated general anesthesia puts patients to sleep. Surgery complication rates may be reduced if intubated general anesthesia is avoided. Additionally, patients not receiving intubated general anesthesia tend to recover more quickly after surgery. It is not yet known whether light sedation is better at reducing complications and length of hospital stay compared to intubated general anesthesia.
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 |
|---|---|---|---|
| Adult Brain Tumor | Adult Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm II (intubated general anesthesia) | Procedure | — | UNRESOLVED |
| Arm I (light sedation) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (light sedation)
- description
- Patients receive light sedation (awake) and undergo craniotomy.
- interventionNames
- Procedure: Arm I (light sedation)
- Procedure: Arm II (intubated general anesthesia)
- Other: Arm II (intubated general anesthesia)
- Other: Arm I (light sedation)
- type
- ACTIVE_COMPARATOR
- label
- Arm II (intubated general anesthesia)
- description
- Patients receive intubated general anesthesia and undergo craniotomy.
- interventionNames
- Procedure: Arm II (intubated general anesthesia)
- Other: Arm II (intubated general anesthesia)
- Procedure: Arm I (light sedation)
- Other: Arm I (light sedation)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Non-pregnant females * Elective craniotomy for supratentorial brain tumors * Primary brain cancer (presumed gliomas with no radiographic or clinical evidence of metastatic disease to the brain) * First craniotomy * American Society of Anesthesiologists (ASA) I-III * Body mass index (BMI) \< 35 Exclusion Criteria: * Posterior fossa tumor/approach for tumor resection requiring the prone position * Traumatic lesions/hematomas * Emergency case * Systemic disease burden with metastatic tumor to the brain * Presence of medical co-morbidities, which, in the opinion of the investigator complicates the surgical procedure or would require additional hospital stay * Necessity of awake procedure requiring intraoperative participation of patient due to the presence of the lesion in eloquent brain areas * Prisoners * Pregnant women
References
Publications (0)
Data not yet available