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

NCT01960543 | Completed Phase 4

• 1 other identifier: ANE-INTRA-2013
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Intrathecal anesthesia; Levobupivacaine; Bupivacaine; Hip fracture

Outcome Measures

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

  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

  7 days post surgery

Other Outcomes (8)

• 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%

  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)

Study Arms (2)

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.

Drug: fentanyl 15 microg; Drug: Bupivacaine 7 mg; Drug: Bupivacaine 9 mg

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.

Drug: fentanyl 15 microg; Drug: Levobupivacaine 7 mg; Drug: Levobupivacaine 9 mg

Interventions

fentanyl 15 microg DRUG

Bupivacaine; Levobupivacaine

Bupivacaine 7 mg DRUG

Bupivacaine

Bupivacaine 9 mg DRUG

Bupivacaine

Levobupivacaine 7 mg DRUG

Levobupivacaine

Levobupivacaine 9 mg DRUG

Levobupivacaine

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Hospital de Sabadell

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (1)

• 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.

  PMID: 30704463 DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Bupivacaine; Levobupivacaine

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician - Anesthesiology

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: October 10, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

ES (1)