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Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture

NCT ID: NCT01647230

Last Updated: 2012-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-02-28

Brief Summary

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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

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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.

Conditions

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Femoral Fracture Blood Pressure Cognitive Impairment

Keywords

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Anaesthesia, spinal Cerebral oximetry Blood pressure Heart rate Cognitive Symptom

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Sabadell

OTHER

Sponsor Role lead

Responsible Party

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Diana L Fernandez Galinski

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diana L Fernández Galinski, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Sabadell - CSPT

Locations

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Hospital de Sabadell - CSPT

Barcelona, Sabadell, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Diana L Fernández Galinski, PhD

Role: CONTACT

Phone: 0034937231010

Email: [email protected]

Francisca Gordo Lacal, Dr

Role: CONTACT

Phone: 0034937231010

Email: [email protected]

Facility Contacts

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Diana L Fernández Galinski, PhD

Role: primary

Francisca Gordo Lacal, Dr

Role: backup

Other Identifiers

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2011612CSPT

Identifier Type: -

Identifier Source: org_study_id