Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy
Completed · Phase 4
Conditions studied: Adult Brain Tumor
In brief
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.
Key facts
- Study ID
- NCT02193568
- Run by
- Ohio State University Comprehensive Cancer Center
- People needed
- 4
- Starts
- 2014-04-30
- Expected to finish
- 2019-01-24
- Last updated by the study team
- 2019-03-13
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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