Effects of Bupivacaine and Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients
Information source: Corporacion Parc Tauli
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Complication of Anesthesia
Intervention: fentanyl 15 microg (Drug); Bupivacaine 7 mg (Drug); Bupivacaine 9 mg (Drug); Levobupivacaine 7 mg (Drug); Levobupivacaine 9 mg (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Corporacion Parc Tauli
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.
Clinical Details
Official title: Comparison of the Effects of Bupivacaine or Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients Who Underwent Hip Fracture Repair
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion of intraoperative time with a decrease of cerebral regional oxygen saturation (SrO2), of at least 20% with respect to baseline values
Secondary outcome: Change in cognitive function after 7 days with respect to preoperative function, measured by means of the Pfeiffer cognitive test
Eligibility
Minimum age: 70 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Hospital de Sabadell, Sabadell, Barcelona 08208, Spain
Additional Information
Starting date: October 2013
Last updated: February 3, 2015
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