Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01647230
• Other study ID #: 2011612CSPT
• Status: Recruiting
• Phase: N/A
• First received: July 19, 2012
• Last updated: July 24, 2012
• Start date: February 2012
• Est. completion date: February 2013

Study information

• Verified date: July 2012
• Source: Hospital de Sabadell
• Contact: Diana L Fernández Galinski, PhD
• Phone: 0034937231010
• Email: DFernandez[@]tauli.cat
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Pressure
• Cognition Disorders
• Cognitive Impairment
• Femoral Fracture
• Femoral Fractures
• Fractures, Bone
• Hip Fractures

Locations

Country	Name	City	State
Spain	Hospital de Sabadell - CSPT	Barcelona	Sabadell

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Sabadell

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	Short Portable Mental Status Questionnaire (SPMSQ)	This test measures cognitive impairment before and after surgery	Once before surgery and at 5th postoperative day	No