Back to resultsEffects of Bupivacaine and Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients
Primary Purpose
Complication of Anesthesia
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
fentanyl 15 microg
Bupivacaine 7 mg
Bupivacaine 9 mg
Levobupivacaine 7 mg
Levobupivacaine 9 mg
Sponsored by
About this trial
This is an interventional treatment trial for Complication of Anesthesia focused on measuring Intrathecal anesthesia, Levobupivacaine, Bupivacaine, Hip fracture
Eligibility Criteria
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
Sites / Locations
- Hospital de Sabadell
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bupivacaine
Levobupivacaine
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Proportion of intraoperative time with a decrease of cerebral regional oxygen saturation (SrO2), of at least 20% with respect to baseline values
Secondary Outcome Measures
Change in cognitive function after 7 days with respect to preoperative function, measured by means of the Pfeiffer cognitive test
Full Information
NCT ID
NCT01960543
First Posted
September 23, 2013
Last Updated
February 3, 2015
Sponsor
Corporacion Parc Tauli
1. Study Identification
Unique Protocol Identification Number
NCT01960543
Brief Title
Effects of Bupivacaine and Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients
Official Title
Comparison of the Effects of Bupivacaine or Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients Who Underwent Hip Fracture Repair
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complication of Anesthesia
Keywords
Intrathecal anesthesia, Levobupivacaine, Bupivacaine, Hip fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Levobupivacaine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
fentanyl 15 microg
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 7 mg
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 9 mg
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine 7 mg
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine 9 mg
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
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)
Title
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)
Title
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)
Title
Doses of vasoactive drugs administered
Time Frame
measured up to the end of surgery (an expected average of 60 minutes)
Title
Adverse events and mortality
Time Frame
30 days
Title
Blood pressure
Time Frame
Measured continuously for the whole duration of surgery (an expected average of 60 minutes)
Title
Heart Rate
Time Frame
Measured continuously for the whole duration of surgery (an expeted average of 60 minutes)
Title
Oxygen saturation during the surgery
Time Frame
Measured continuously for the whole duration of surgery (an expected average of 60 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital de Sabadell
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
30704463
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Bupivacaine and Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients
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