Complication of AnesthesiaPhase 4NCT01960543
Effects of Bupivacaine and Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients
A Phase 4 study testing fentanyl 15 microg, Bupivacaine 7 mg and Bupivacaine 9 mg in people with Complication of Anesthesia, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Complication of Anesthesia
- What is being tested?
- fentanyl 15 microg, Bupivacaine 7 mg and Bupivacaine 9 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2013to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Bupivacaine or Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients Who Underwent Hip Fracture Repair
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
- Being tested
- fentanyl 15 microg, Bupivacaine 7 mg, Bupivacaine 9 mg, Levobupivacaine 7 mg, Levobupivacaine 9 mg
- Keywords
- Intrathecal anesthesia, Levobupivacaine, Bupivacaine, Hip fracture
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanyl 15 microgDrug
Bupivacaine 7 mgDrug
Bupivacaine 9 mgDrug
Levobupivacaine 7 mgDrug
Levobupivacaine 9 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: fentanyl 15 microg; Drug: Levobupivacaine 7 mg; Drug: Levobupivacaine 9 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of intraoperative time with a decrease of cerebral regional oxygen saturation (SrO2), of at least 20% with respect to baseline values
Measured: 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
Measured: 7 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complication of AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana L Fernandez Galinski, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960543
- Sponsor's protocol ID
- ANE-INTRA-2013
- Status last verified
- Feb 2015
- First submitted
- 23 Sep 2013
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30704463
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Bupivacaine or Levobupivacaine on Cerebral Oxygenation During Intrathecal Anesthesia in Elderly Patients Who Underwent Hip Fracture Repair
- ClinicalTrials.gov ID
- NCT01960543
- Acronym / sponsor ID
- ANE-INTRA-2013
- Conditions
- Complication of Anesthesia
- Keywords
- Intrathecal anesthesia, Levobupivacaine, Bupivacaine, Hip fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Drug: fentanyl 15 microg, Drug: Bupivacaine 7 mg, Drug: Bupivacaine 9 mgIntrathecal 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 | Drug: fentanyl 15 microg, Drug: Levobupivacaine 7 mg, Drug: Levobupivacaine 9 mgIntrathecal 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
- Derived from this study: PubMed 30704463Vives 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.
Related trials for Complication of Anesthesia
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fentanyl 15 microg, Bupivacaine 7 mg and Bupivacaine 9 mg in people with Complication of Anesthesia, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01960543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.