NCT01960543

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

Comparison of the Effects of Bupivacaine or Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients Who Underwent Hip Fracture Repair

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Complication of Anesthesia

Interventions

Type	Name	Description
DRUG	fentanyl 15 microg
DRUG	Bupivacaine 7 mg
DRUG	Bupivacaine 9 mg
DRUG	Levobupivacaine 7 mg
DRUG	Levobupivacaine 9 mg

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-10-10
• Last updated: 2015-02-04

Locations

1 site across 1 country: Spain