Complication of Anesthesia
Conditions
Keywords
Intrathecal anesthesia, Levobupivacaine, Bupivacaine, Hip fracture
Brief summary
Elderly patients with hip fracture are frail due to associated comorbidity. In these situations, regional anesthesia is recommended as it is associated to less postoperative cognitive dysfunction. However, hypotension during the process may impair ischemic cardiopathy and induce a cerebrovascular stroke. Selection of the right anesthetic agent and the administration of vasoactive drugs during the process can minimize these risks. Although bupivacaine and levobupivacaine share pharmacokinetic and pharmacodynamic properties, the studies show conflicting results. The aim of this study is to investigate if there are clinically relevant differences between these two drugs in terms of hemodynamic parameters during the surgical process with special focus on the effects on regional cerebral oximetry and cognitive status after surgery.
Interventions
DRUGfentanyl 15 microg
DRUGBupivacaine 7 mg
DRUGBupivacaine 9 mg
DRUGLevobupivacaine 7 mg
DRUGLevobupivacaine 9 mg
Sponsors
Corporacion Parc Tauli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients older than 70 years old who undergo major surgery for hip fracture and will receive intrathecal anesthesia 2. Patients in which it is considered adequate, according to the usual clinical practice, the use of bupivacaine or levobupivacaine as part of the intrathecal anesthesia 3. Patients who give their informed consent to participate in the study
Exclusion criteria
1. Patients allergic to anesthetic drugs to be used in the protocol or to local anesthetics amida type. 2. Patients with severe aortic stenosis or hemodynamic instability. 3. Patients who refuse the anesthetic technique or contraindication for the use of the intrathecal technique. 4. Patients with severe cognitive impairment previous to the intervention (defined by a score in the Pfeiffer test of 8-10 errors) 5. Patients in which the use of bupivacaine or levobupivacaine is contraindicated as part of the intrathecal anesthesia 6. Any condition that, in the investigator's opinion, could pose a risk to the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of intraoperative time with a decrease of cerebral regional oxygen saturation (SrO2), of at least 20% with respect to baseline values | Measured continuously during surgery (an expected average of 60 minutes) |
Secondary
| Measure | Time frame |
|---|---|
| Change in cognitive function after 7 days with respect to preoperative function, measured by means of the Pfeiffer cognitive test | 7 days post surgery |
Other
| Measure | Time frame |
|---|---|
| Changes in cerebral regional oxygen saturation induced by the administration of vasoconstrictor drugs | Measured continuously for the whole duration of surgery (an expected average of 60 minutes) |
| Doses of vasoactive drugs administered | measured up to the end of surgery (an expected average of 60 minutes) |
| Adverse events and mortality | 30 days |
| Proportion of intraoperative time with a decrease in values of cerebral regional oxygen saturation to 40% or 50% | Measured continuously during surgery (an expected average of 60 minutes) |
| Heart Rate | Measured continuously for the whole duration of surgery (an expeted average of 60 minutes) |
| Oxygen saturation during the surgery | Measured continuously for the whole duration of surgery (an expected average of 60 minutes) |
| Blood pressure | Measured continuously for the whole duration of surgery (an expected average of 60 minutes) |
| Time to first drop of cerebral regional oxygen saturation below 40% or 50% | Assessed up to the end of surgery (an expected average of 60 minutes) |
Countries
Spain
Outcome results
None listed