Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture

This study is currently recruiting participants.
Verified July 2012 by Hospital de Sabadell
Sponsor:
Information provided by (Responsible Party):
Diana L Fernandez Galinski, Hospital de Sabadell
ClinicalTrials.gov Identifier:
NCT01647230
First received: July 19, 2012
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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.


Condition
Femoral Fracture
Blood Pressure
Cognitive Impairment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture

Resource links provided by NLM:


Further study details as provided by Hospital de Sabadell:

Primary Outcome Measures:
  • Cerebral Oximetry [ Time Frame: Initial, 3 times after spinal block and every 10 minutes during surgery ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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:
  • Short Portable Mental Status Questionnaire (SPMSQ) [ Time Frame: Once before surgery and at 5th postoperative day ] [ Designated as safety issue: No ]
    This test measures cognitive impairment before and after surgery


Estimated Enrollment: 70
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647230

Contacts
Contact: Diana L Fernández Galinski, PhD 0034937231010 ext 21277 DFernandez@tauli.cat
Contact: Francisca Gordo Lacal, Dr 0034937231010 ext 21277 fgordo@tauli.cat

Locations
Spain
Hospital de Sabadell - CSPT Recruiting
Barcelona, Sabadell, Spain, 08208
Contact: Diana L Fernández Galinski, PhD    0034937231010 ext 21277    DFernandez@tauli.cat   
Contact: Francisca Gordo Lacal, Dr    0034937231010 ext 21277    fgordo@tauli.cat   
Principal Investigator: Diana L Fernández Galinski, PhD         
Sponsors and Collaborators
Hospital de Sabadell
Investigators
Principal Investigator: Diana L Fernández Galinski, PhD Hospital de Sabadell - CSPT
  More Information

No publications provided

Responsible Party: Diana L Fernandez Galinski, PhD, Hospital de Sabadell
ClinicalTrials.gov Identifier: NCT01647230     History of Changes
Other Study ID Numbers: 2011612CSPT
Study First Received: July 19, 2012
Last Updated: July 24, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital de Sabadell:
Anaesthesia, spinal
Cerebral oximetry
Blood pressure
Heart rate
Cognitive Symptom

Additional relevant MeSH terms:
Hip Injuries
Femoral Fractures
Fractures, Bone
Hip Fractures
Cognition Disorders
Wounds and Injuries
Leg Injuries
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014