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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Complication of Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bupivacaine

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.

Group Type ACTIVE_COMPARATOR

fentanyl 15 microg

Intervention Type DRUG

Bupivacaine 7 mg

Intervention Type DRUG

Bupivacaine 9 mg

Intervention Type DRUG

Levobupivacaine

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.

Group Type ACTIVE_COMPARATOR

fentanyl 15 microg

Intervention Type DRUG

Levobupivacaine 7 mg

Intervention Type DRUG

Levobupivacaine 9 mg

Intervention Type DRUG

Interventions

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fentanyl 15 microg

Intervention Type DRUG

Bupivacaine 7 mg

Intervention Type DRUG

Bupivacaine 9 mg

Intervention Type DRUG

Levobupivacaine 7 mg

Intervention Type DRUG

Levobupivacaine 9 mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No