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Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture

2012年7月24日更新者：Diana L Fernandez Galinski、Hospital de Sabadell

Observational Study of Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture

The aim of this study is to observe how the hemodynamic changes induced by spinal blockade affect cerebral oxygenation. Elderly patients are very frail. Hypotension is very frequent during spinal anaesthesia. Bradycardia is other side effect of regional anaesthesia affecting cardiac output and cerebral blood flow. These complications of spinal anaesthesia could decline cognitive function. In this way a non invasive monitoring technique as cerebral oximetry is useful for the safety of anesthetic procedure.

研究概览

地位

未知

条件

详细说明

Patients aged 70 years old with hip fracture presenting for surgical repair under intrathecal anaesthesia performed with bupivacaine or L bupivacaine (dose 7 - 9 mg). Preoperative haemoglobin and drugs consumption are registered. All patients receive supplemental oxygen during surgery. Cerebral oximetry, blood pressure, heart rate and oxygen arterial saturation are measured. Level and duration of sensory and motor block are registered. The study observes if there is any correlation between cerebral oximetry and these hemodynamic parameters.

The investigators also observe if there is any correlation between cerebral oximetry and cognitive function evaluated pre and postoperatively by SPMSQ test.

Postoperative SPMSQ test will be performed on the 5th postoperative day and the complications registered.Patients will be followed for the duration of acute hospital stay.

研究类型

观察性的

注册 (预期的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

西班牙
- Sabadell
  - Barcelona、Sabadell、西班牙、08208
    - 招聘中
    - Hospital de Sabadell - CSPT
    - 接触：
      
      Diana L Fernández Galinski, PhD
      
      电话号码：21277 0034937231010
      
      邮箱：DFernandez@tauli.cat
    - 接触：
      
      Francisca Gordo Lacal, Dr
      
      电话号码：21277 0034937231010
      
      邮箱：fgordo@tauli.cat
    - 首席研究员：
      
      Diana L Fernández Galinski, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

70年及以上 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients aged > 70 years old with hip fracture undergoing surgery under spinal anaesthesia.

描述

Inclusion criteria:

Patients aged >70 years old with hip fracture.
No contraindication for spinal anaesthesia.

Exclusion Criteria:

Allergic reaction to local anesthetics.
Severe aortic stenosis.
Local infection.
SPMSQ test >7 errors.
Patient refusal

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Cerebral Oximetry 大体时间：Initial, 3 times after spinal block and every 10 minutes during surgery	Changes in cerebral oxymetry measured initially (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured evey 10 minutes to obtain the mean of all the values.	Initial, 3 times after spinal block and every 10 minutes during surgery
Mean Arterial Pressure (MAP) 大体时间：Initial, 3 times after spinal block and every 10 minutes during surgery	Changes in MAP measured initially (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured every 10 minutes to obtain the mean of all the values	Initial, 3 times after spinal block and every 10 minutes during surgery
Heart Rate (HR) 大体时间：Initial, 3 times after spinal block and every 10 minutes during surgery	Changes in HR (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured every 10 minutes to obtain the mean of all the values.	Initial, 3 times after spinal block and every 10 minutes during surgery
Oxygen arterial saturation (OSat) 大体时间：Initial, 3 times after spinal block and every 10 minutes during surgery	Changes in OSat measured initially (basal), 10, 20 and 30 minutes after spinal block. During surgery oximetry is measured every 10 minutes to obtain the mean of all the values.	Initial, 3 times after spinal block and every 10 minutes during surgery

次要结果测量

结果测量	措施说明	大体时间
Short Portable Mental Status Questionnaire (SPMSQ) 大体时间：Once before surgery and at 5th postoperative day	This test measures cognitive impairment before and after surgery	Once before surgery and at 5th postoperative day

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hospital de Sabadell

调查人员

首席研究员：Diana L Fernández Galinski, PhD、Hospital de Sabadell - CSPT

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年2月1日

研究完成 (预期的)

2013年2月1日

研究注册日期

首次提交

2012年7月19日

首先提交符合 QC 标准的

2012年7月20日

首次发布 (估计)

2012年7月23日

研究记录更新

最后更新发布 (估计)

2012年7月25日

上次提交的符合 QC 标准的更新

2012年7月24日

最后验证

2012年7月1日