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Clinical Trials/NCT01647230
NCT01647230
Unknown
Not Applicable

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

Hospital de Sabadell1 site in 1 country70 target enrollmentFebruary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Femoral Fracture
Sponsor
Hospital de Sabadell
Enrollment
70
Locations
1
Primary Endpoint
Cerebral Oximetry
Last Updated
13 years ago

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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
February 2013
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital de Sabadell
Responsible Party
Principal Investigator
Principal Investigator

Diana L Fernandez Galinski

PhD

Hospital de Sabadell

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Outcomes

Primary Outcomes

Cerebral Oximetry

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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 Outcomes

  • Short Portable Mental Status Questionnaire (SPMSQ)(Once before surgery and at 5th postoperative day)

Study Sites (1)

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