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

Complication of Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960543
• Other study ID #: ANE-INTRA-2013
• Status: Completed
• Phase: Phase 4
• First received: September 23, 2013
• Last updated: February 3, 2015
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complication of Anesthesia

Intervention

Drug:
• fentanyl 15 microg

• Bupivacaine 7 mg

• Bupivacaine 9 mg

• Levobupivacaine 7 mg

• Levobupivacaine 9 mg

Locations

Country	Name	City	State
Spain	Hospital de Sabadell	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	Yes
Other	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)	Yes
Other	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)	Yes
Other	Doses of vasoactive drugs administered		measured up to the end of surgery (an expected average of 60 minutes)	Yes
Other	Adverse events and mortality		30 days	Yes
Other	Blood pressure		Measured continuously for the whole duration of surgery (an expected average of 60 minutes)	Yes
Other	Heart Rate		Measured continuously for the whole duration of surgery (an expeted average of 60 minutes)	Yes
Other	Oxygen saturation during the surgery		Measured continuously for the whole duration of surgery (an expected average of 60 minutes)	Yes
Primary	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)	Yes
Secondary	Change in cognitive function after 7 days with respect to preoperative function, measured by means of the Pfeiffer cognitive test		7 days post surgery	Yes