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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


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


Minimum age: 70 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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