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Bupivacaine vs Levobupivacaine for Cerebral Oxygenation in Hip Fracture Repair
NCT01960543Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2013
- Primary completion
- Dec 2014
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- levobupivacaine
- Conditions
- hip fracture
01
Overview
Phase 4, randomised trial of levobupivacaine in hip fracture (2 arms), sponsored by Hospital Universitari Parc Taulí. Primary endpoint: Proportion of intraoperative time with a decrease of cerebral regional oxygen saturation (SrO2) of at least 20% with respect to baseline values. Started Oct 2013; status: completed.
02
Design
2 arms- Study design
- Randomized
Levobupivacaine
Levobupivacaine 0.5% (7-9mg) + Fentanyl 15ug
Bupivacaine
Bupivacaine 0.5% (7-9mg) + Fentanyl 15ug
03
Who it enrols
Elderly patients (>70 years) undergoing major surgery for hip fracture with intrathecal anesthesia.
04
Endpoints
Primary
Proportion of intraoperative time with a decrease of cerebral regional oxygen saturation (SrO2) of at least 20% with respect to baseline values
Secondary
Change in cognitive function after 7 days with respect to preoperative function
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