Clinical trial NCT01647230: Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture
Official title: Observational Study of Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Femoral Fracture
Blood Pressure
Cognitive Impairment
Keywords: Anaesthesia, spinal
Cerebral oximetry
Blood pressure
Heart rate
Cognitive Symptom
Lead sponsor: Hospital de Sabadell
Sponsor class: OTHER
First posted: 2012-07-23
Enrollment: 70
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged \> 70 years old with hip fracture undergoing surgery under spinal anaesthesia.

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.

Eligibility 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

Primary outcomes:
measure: Cerebral Oximetry
timeFrame: Initial, 3 times after spinal block and every 10 minutes during surgery
measure: Mean Arterial Pressure (MAP)
timeFrame: Initial, 3 times after spinal block and every 10 minutes during surgery
measure: Heart Rate (HR)
timeFrame: Initial, 3 times after spinal block and every 10 minutes during surgery
measure: Oxygen arterial saturation (OSat)
timeFrame: Initial, 3 times after spinal block and every 10 minutes during surgery
Secondary outcomes:
measure: Short Portable Mental Status Questionnaire (SPMSQ)
timeFrame: Once before surgery and at 5th postoperative day
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de Sabadell - CSPT
state: Sabadell
Study officials:
affiliation: Hospital de Sabadell - CSPT
name: Diana L Fernández Galinski, PhD
role: PRINCIPAL_INVESTIGATOR
References: