Clinical trial NCT02193568: Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy
Official title: A Prospective, Single-Blinded, Randomized Study of Awake vs Intubated General Anesthesia in Patients Undergoing Elective Craniotomy for Supratentorial Glioma Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adult Brain Tumor
Keywords: Supratentorial Glioma
Craniotomy
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 4
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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 resource utilization between the two groups. II. To assess the frequency of post-operative delirium. III. To measure patient perceptions. IV. To track patient complications during hospital stay - nausea/vomiting, pain, hematology/lab stability, hemodynamic stability.

V. To track re-admission and extended hospital stay rates. VI. To compare cost of both approaches.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive light sedation (awake) and undergo craniotomy.

ARM II: Patients receive intubated general anesthesia and undergo craniotomy.

After completion of study, patients are followed up at 1month and 1 year.

Eligibility criteria: 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

Primary outcomes:
measure: Compare overall hospital length of stay for patients in each of 2 arms
timeFrame: Up to 1 year
Secondary outcomes:
measure: Compare resource utilization between two groups
timeFrame: Up to 1 year
measure: Assess the frequency of post-operative delirium
timeFrame: Up to 1 year
measure: Measure patient perceptions
timeFrame: Up to 1 year
measure: Track patient complications during hospital stay
timeFrame: Up to 1 year
measure: Track re-admission and extended hospital stay rates
timeFrame: Up to 1 year from the date of surgery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: James Elder, MD
role: PRINCIPAL_INVESTIGATOR
References: