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Comparison of the effects of bupivacain or levobupivacain on cerebral oxigenation during intradural anesthesia in elderly patients who undergo hip replacement surgery

Comparison of the effects of bupivacain or levobupivacain on cerebral oxigenation during intradural anesthesia in elderly patients who undergo major orthopaedic surgery for hip replacement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-000846-20-ES
Enrollment
Unknown
Registered
2013-04-09
Start date
2013-06-24
Completion date
Unknown
Last updated
2015-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intradural anaesthesia MedDRA version: 14.1 Level: PT Classification code 10002091 Term: Anaesthesia System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: BUPIVACAÍNA HIPERBÁRICA BRAUN 0,5% MINIPLASCO Product Name: Bupivacaine Pharmaceutical Form: Solution for injection INN or Proposed INN: BUPIVACAINE CAS Number: 2180-92-9 Concentration uni

Sponsors

Fundació Parc Taulí
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients older than 70 years old who undergo major orthopaedic surgery for hip replacement and will receive intradural anaesthesia 2. Patients who give their informed consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 56

Exclusion criteria

Exclusion criteria: 1. Patients allergic to anaesthetic drugs to be used in the protocol 2. Patients with severe aortic estenosis 3. Patients who refuse the anaesthetic technique 4. Patients with severe cognitive impairment previous to the intervention (defined by a score in the Pfeiffer test of 8-10 errors) 5. Any condition that, in the investigator's opinion, could pose a risk to the patient

Design outcomes

Primary

MeasureTime frame
Main Objective: The main objective is to assess the effect of bupivacaine or levobupivacaine on peroperatory regional cerebral oximetry during anaesthesia in elderly patients undergoing hip replacement surgery;Secondary Objective: Compare between patients treated with bupivacaine or levobupivacaine the following parameters: 1. Change in cognitive function after surgery 2. Hemodynamic changes induced by anaesthetic blockade and administration of vasoconstrictor drugs during anaesthesia 3. Characteristics of sensorial and motor blockade induced by intradural anaesthesia 4. Degree of intrasurgical bleeding 5. Changes in renal function 6. Clinical complications during hospitalization 7. Mortality after 30 days;Primary end point(s): Proportion of intraoperative time with a decrease or cerebral regional saturation (SrO2), of at least 20% with respect to baseline values;Timepoint(s) of evaluation of this end point: During the surgery—

Secondary

MeasureTime frame
Secondary end point(s): ? Change in cognitive function after 5 or 7 days with respect to preoperative function, measured by means of the Pfeiffer cognitive test;Timepoint(s) of evaluation of this end point: Measured at day 5 or 7 post-surgery—

Countries

Spain

Contacts

Public ContactOficina de Recerca

Fundació Parc Taulí

afarre@tauli.cat

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026