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NCT Number: NCT01960543

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

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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Key information

Conditions

Complication of Anesthesia Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de Sabadell

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients older than 70 years old who undergo major surgery for hip fracture and will receive intrathecal anesthesia
  • 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
  • Patients who give their informed consent to participate in the study

Exclusion criteria

  • Patients allergic to anesthetic drugs to be used in the protocol or to local anesthetics amida type.
  • Patients with severe aortic stenosis or hemodynamic instability.
  • Patients who refuse the anesthetic technique or contraindication for the use of the intrathecal technique.
  • Patients with severe cognitive impairment previous to the intervention (defined by a score in the Pfeiffer test of 8-10 errors)
  • Patients in which the use of bupivacaine or levobupivacaine is contraindicated as part of the intrathecal anesthesia
  • Any condition that, in the investigator's opinion, could pose a risk to the patient

Treatment and study plan

fentanyl 15 microg

Drug

Bupivacaine 7 mg

Drug

Bupivacaine 9 mg

Drug

Levobupivacaine 7 mg

Drug

Levobupivacaine 9 mg

Drug

Primary outcomes

  1. Proportion of intraoperative time with a decrease of cerebral regional oxygen saturation (SrO2), of at least 20% with respect to baseline values

    Time frame: Measured continuously during surgery (an expected average of 60 minutes)

Secondary outcomes

  1. Change in cognitive function after 7 days with respect to preoperative function, measured by means of the Pfeiffer cognitive test

    Time frame: 7 days post surgery

Other outcomes

  1. Proportion of intraoperative time with a decrease in values of cerebral regional oxygen saturation to 40% or 50%

    Time frame: Measured continuously during surgery (an expected average of 60 minutes)

  2. Time to first drop of cerebral regional oxygen saturation below 40% or 50%

    Time frame: Assessed up to the end of surgery (an expected average of 60 minutes)

  3. Changes in cerebral regional oxygen saturation induced by the administration of vasoconstrictor drugs

    Time frame: Measured continuously for the whole duration of surgery (an expected average of 60 minutes)

  4. Doses of vasoactive drugs administered

    Time frame: measured up to the end of surgery (an expected average of 60 minutes)

  5. Adverse events and mortality

    Time frame: 30 days

  6. Blood pressure

    Time frame: Measured continuously for the whole duration of surgery (an expected average of 60 minutes)

  7. Heart Rate

    Time frame: Measured continuously for the whole duration of surgery (an expeted average of 60 minutes)

  8. Oxygen saturation during the surgery

    Time frame: Measured continuously for the whole duration of surgery (an expected average of 60 minutes)

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 10, 2013
Registry last updated
Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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