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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine | Active Comparator | Intrathecal administration of bupivacaine 0.5% Doses: Bupivacaine 7 mg plus fentanyl 15 ug for patients shorter than 160 cm. Bupivacaine 9 mg plus fentanyl 15 ug for patients equal or taller than 160 cm or hip replacement. |
|
| Levobupivacaine | Active Comparator | Intrathecal administration of levobupivacaine 0.5%: Doses: Levobupivacaine 7 mg plus fentanyl 15 ug for patients shorter than 160 cm. Levobupivacaine 9 mg plus fentanyl 15 ug for patients equal or taller than 160 cm or hip replacement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fentanyl 15 microg | Drug |
| ||
| Bupivacaine 7 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of intraoperative time with a decrease of cerebral regional oxygen saturation (SrO2), of at least 20% with respect to baseline values | Measured continuously during surgery (an expected average of 60 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive function after 7 days with respect to preoperative function, measured by means of the Pfeiffer cognitive test | 7 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of intraoperative time with a decrease in values of cerebral regional oxygen saturation to 40% or 50% | Measured continuously during surgery (an expected average of 60 minutes) | |
| Time to first drop of cerebral regional oxygen saturation below 40% or 50% |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Sabadell | Sabadell | Barcelona | 08208 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30704463 | Derived | Vives R, Fernandez-Galinski D, Gordo F, Izquierdo A, Oliva JC, Colilles C, Pontes C. Effects of bupivacaine or levobupivacaine on cerebral oxygenation during spinal anesthesia in elderly patients undergoing orthopedic surgery for hip fracture: a randomized controlled trial. BMC Anesthesiol. 2019 Jan 31;19(1):17. doi: 10.1186/s12871-019-0682-1. |
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| Drug |
|
| Bupivacaine 9 mg | Drug |
|
| Levobupivacaine 7 mg | Drug |
|
| Levobupivacaine 9 mg | Drug |
|
| Assessed up to the end of surgery (an expected average of 60 minutes) |
| Changes in cerebral regional oxygen saturation induced by the administration of vasoconstrictor drugs | Measured continuously for the whole duration of surgery (an expected average of 60 minutes) |
| Doses of vasoactive drugs administered | measured up to the end of surgery (an expected average of 60 minutes) |
| Adverse events and mortality | 30 days |
| Blood pressure | Measured continuously for the whole duration of surgery (an expected average of 60 minutes) |
| Heart Rate | Measured continuously for the whole duration of surgery (an expeted average of 60 minutes) |
| Oxygen saturation during the surgery | Measured continuously for the whole duration of surgery (an expected average of 60 minutes) |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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