Cerebral Near-Infrared Spectroscopy and Hypotensive Anesthesia in Patients Undergoing Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Oxygen Desaturation Incidences
研究概览
简要总结
We plan to investigate the relationship between hypotensive epidural anesthesia for hip arthroplasty and cerebral oxygen saturation.
详细描述
The relationship between cerebral oxygenation and blood pressure in patients undergoing hypotensive epidural anesthesia has not been completely elucidated. Previous publications have demonstrated a low incidence of post-op cognitive dysfunction in patients undergoing hypotensive epidural anesthesia for total hip replacement (1-3) and that cerebral blood flow velocity is preserved as measured by transcranial Doppler (4). An earlier investigation by Dr. Yadeau demonstrated infrequent cerebral oxygen desaturation in spontaneously breathing patients undergoing shoulder arthroscopy, even in the presence of hypotension (4), but did not investigate outcomes in the cognitive domain or have a control group of patients undergoing surgery with general anesthesia. There has only been one study looking at cerebral oxygenation and hip surgery, which was performed in elderly patients with fractures. It demonstrated that patients with low pre-op regional cerebral oxygen saturation (rSO2) had higher incidence of delirium (5) but many of those patients had surgery under general anesthesia. Given the costs associated with post-op delirium, cognitive dysfunction and stroke (6) and based on the fact that previous publications from this institution have demonstrated both a low incidence of cognitive dysfunction and preservation of cerebral blood flow velocity using this anesthetic technique, we hypothesized that cerebral oxygen desaturation will not occur in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18-80 years old undergoing unilateral total hip arthroplasty
- •Hypotensive epidural anesthesia
排除标准
- •Contraindication to controlled hypotension and/or neuraxial anesthesia.
- •Severe pulmonary hypertension or pre-op systolic blood pressure reading >150 mm Hg
- •Moderate to severe valvular stenosis.
- •History of stroke, dementia, or post-op delirium
- •Prior OSA diagnosis
- •History of benzodiazepine use (regular use for longer than 3 months)
- •Chronic renal or hepatic disease (renal failure, history of liver failure, cirrhosis)
- •History of alcoholism or heavy alcohol intake (defined as averaging more than 3 drinks per night; recovery is OK)
- •Parkinson's disease
- •Severe chronic pulmonary disease
- •Total anterior hip approach being used
- •Hip resurfacing procedure
- •Non-English Speaking*
- •Questionnaires being used to assess mental status are only validated in English.
结局指标
主要结局
Oxygen Desaturation Incidences
时间窗: Intra-operation (when the patient enters the operating room, up to 4 hours)
The number of participant's experiencing an intra-operative cerebral oxygen desaturation event. Measured in the number of patients, beginning with the time the patients' enters the operating room and up to 4 hours.
次要结局
- Duration of Oxygen Desaturation(Intra-op ( during the time the patient is in the operating room, up to 4 hours))
- Presence of Post-operative Delirium(Post-op Day 1, Post-op Day 2)
- Patients With Cognitive Dysfunction(Post-op Day 1, Post-op Day 2)