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

• Conditions: Intradural anaesthesia; MedDRA version: 14.1Level: PTClassification code 10002091Term: AnaesthesiaSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-000846-20-ES
• Lead Sponsor: Fundació Parc Taulí

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-09
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>1. Change in cognitive function after surgery<br>2. Hemodynamic changes induced by anaesthetic blockade and administration of vasoconstrictor drugs during anaesthesia<br>3. Characteristics of sensorial and motor blockade induced by intradural anaesthesia<br>4. Degree of intrasurgical bleeding<br>5. Changes in renal function <br>6. Clinical complications during hospitalization<br>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 Outcome Measures

Name	Time	Method
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