Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy (NCT02193568) | Clinical Trial Compass
CompletedPhase 4
Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy
United States4 participantsStarted 2014-04-30
Plain-language 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 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compare overall hospital length of stay for patients in each of 2 arms
Timeframe: Up to 1 year
Trial details
NCT IDNCT02193568
SponsorOhio State University Comprehensive Cancer Center