A Prospective, Single-Blinded, Randomized Study of Awake vs Intubated General Anesthesia in Patients Undergoing Elective Craniotomy for Supratentorial Glioma Resection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Compare overall hospital length of stay for patients in each of 2 arms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm I (light sedation)
Patients receive light sedation (awake) and undergo craniotomy.
干预措施: Arm I (light sedation) (Procedure)
Arm I (light sedation)
Patients receive light sedation (awake) and undergo craniotomy.
干预措施: Arm II (intubated general anesthesia) (Procedure)
Arm I (light sedation)
Patients receive light sedation (awake) and undergo craniotomy.
干预措施: Arm II (intubated general anesthesia) (Other)
Arm I (light sedation)
Patients receive light sedation (awake) and undergo craniotomy.
干预措施: Arm I (light sedation) (Other)
Arm II (intubated general anesthesia)
Patients receive intubated general anesthesia and undergo craniotomy.
干预措施: Arm II (intubated general anesthesia) (Procedure)
Arm II (intubated general anesthesia)
Patients receive intubated general anesthesia and undergo craniotomy.
干预措施: Arm II (intubated general anesthesia) (Other)
Arm II (intubated general anesthesia)
Patients receive intubated general anesthesia and undergo craniotomy.
干预措施: Arm I (light sedation) (Procedure)
Arm II (intubated general anesthesia)
Patients receive intubated general anesthesia and undergo craniotomy.
干预措施: Arm I (light sedation) (Other)
结局指标
主要结局
Compare overall hospital length of stay for patients in each of 2 arms
时间窗: Up to 1 year
Will be summarized for each arm and compared between light sedation and general anesthesia arm using two-sample test. Regression model will also be used to study the association between the length of stay and the type of anesthesia with potential confounder variables.
次要结局
- Compare resource utilization between two groups(Up to 1 year)
- Assess the frequency of post-operative delirium(Up to 1 year)
- Measure patient perceptions(Up to 1 year)
- Track patient complications during hospital stay(Up to 1 year)
- Track re-admission and extended hospital stay rates(Up to 1 year from the date of surgery)
研究者
James Elder
Principal Investigator
Ohio State University Comprehensive Cancer Center