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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01647230
Enrollment
70
Registered
2012-07-23
Start date
2012-02-29
Completion date
2013-02-28
Last updated
2012-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Cognitive Impairment, Femoral Fracture

Keywords

Anaesthesia, spinal, Cerebral oximetry, Blood pressure, Heart rate, Cognitive Symptom

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.

Interventions

None listed

Sponsors

Hospital de Sabadell
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cerebral OximetryInitial, 3 times after spinal block and every 10 minutes during surgeryChanges 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)Initial, 3 times after spinal block and every 10 minutes during surgeryChanges 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)Initial, 3 times after spinal block and every 10 minutes during surgeryChanges 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)Initial, 3 times after spinal block and every 10 minutes during surgeryChanges 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

MeasureTime frameDescription
Short Portable Mental Status Questionnaire (SPMSQ)Once before surgery and at 5th postoperative dayThis test measures cognitive impairment before and after surgery

Countries

Spain

Contacts

Primary ContactDiana L Fernández Galinski, PhD
DFernandez@tauli.cat0034937231010
Backup ContactFrancisca Gordo Lacal, Dr
fgordo@tauli.cat0034937231010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026