Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture

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.

Study Overview

• Status: Unknown
• Conditions: Femoral Fracture; Cognitive Impairment; Blood Pressure

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 Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• Spain
  • Sabadell
    • Barcelona, Sabadell, Spain, 08208
      • Recruiting
      • Hospital de Sabadell - CSPT
      • Contact: Diana L Fernández Galinski, PhD; Phone Number: 21277 0034937231010; Email: DFernandez@tauli.cat
      • Contact: Francisca Gordo Lacal, Dr; Phone Number: 21277 0034937231010; Email: fgordo@tauli.cat
      • Principal Investigator: Diana L Fernández Galinski, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

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

Collaborators and Investigators

• Sponsor: Hospital de Sabadell
• Investigators: Principal Investigator: Diana L Fernández Galinski, PhD, Hospital de Sabadell - CSPT

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Study Completion (Anticipated): February 1, 2013

Study Registration Dates

• First Submitted: July 19, 2012
• First Submitted That Met QC Criteria: July 20, 2012
• First Posted (Estimate): July 23, 2012

Study Record Updates

• Last Update Posted (Estimate): July 25, 2012
• Last Update Submitted That Met QC Criteria: July 24, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Blood pressure; Cerebral oximetry; Heart rate; Anaesthesia, spinal; Cognitive Symptom
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Hip Injuries; Femoral Fractures; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 2011612CSPT