Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture

• Conditions: Femoral Fracture; Blood Pressure; Cognitive Impairment

• Registration Number: NCT01647230
• Lead Sponsor: Hospital de Sabadell

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.

Study Timeline

• Study Start: 2012-02
• Status Verified: 2012-07
• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-20
• Study First Posted: 2012-07-23
• Last Update Submitted: 2012-07-24
• Last Update Posted: 2012-07-25
• Study Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cerebral Oximetry	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.
Mean Arterial Pressure (MAP)	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
Heart Rate (HR)	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.
Oxygen arterial saturation (OSat)	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.

Secondary Outcome Measures

Name	Time	Method
Short Portable Mental Status Questionnaire (SPMSQ)	Once before surgery and at 5th postoperative day	This test measures cognitive impairment before and after surgery

Trial Locations

Locations (1)

Hospital de Sabadell - CSPT; 🇪🇸 Barcelona, Sabadell, Spain