drugset / Trial / NCT01960543

Effects of Bupivacaine and Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients

NCT01960543

Phase 4 Completed 58 enrolled Corporacion Parc Tauli
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-10
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 7 mg Intrathecal
Comparator Bupivacaine Other / unclassified 9 mg Intrathecal
Comparator Levobupivacaine Other / unclassified 7 mg Intrathecal
Comparator Levobupivacaine Other / unclassified 9 mg Intrathecal
Comparator Fentanyl Other / unclassified 15 ug Intrathecal

Indications

No indication recorded.