Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Femoral Fracture, Blood Pressure, Cognitive Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Oximetry | 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) | 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) | 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) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Portable Mental Status Questionnaire (SPMSQ) | This test measures cognitive impairment before and after surgery | Once before surgery and at 5th postoperative day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anaesthesia, spinal, Cerebral oximetry, Blood pressure, Heart rate, Cognitive Symptom