Status:
COMPLETED
Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Adult Brain Tumor
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
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 comp...
Detailed Description
PRIMARY OBJECTIVES: I. To compare the overall hospital length of stay (LOS) in patients undergoing craniotomy with light sedation vs. general anesthesia. SECONDARY OBJECTIVES: I. To compare resourc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02193568
Start Date
April 30 2014
End Date
January 24 2019
Last Update
March 13 2019
Active Locations (1)
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1
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210