Post Operative Cognitive Dysfunction After Breast Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Padova
About this trial
Aim of this trial is to define if Post-Operative Cognitive Dysfunction, detected analyzing changes between pre-operative and post-operative Neurocognitive Test, and Postoperative Delirium, relate to concentration of effector's site concentration of propofol and remifentanil TCI and to the common intraoperative neuromonitoring values as well as to Pupillometry values (in particular Pupil Diameter, Pupil Latency, and Maximum Contraction Velcoity).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
General Anaesthesia delivered with Propofol and Remifentanil with Targeted Controlled Infusion
Use of Laryngeal Mask airway
Disqualifiers
Neurological pathologies
Haemodynamical instability during surgery
Trial population
Women subjected to breast surgery in general anaesthesia with Laryngeal-Mask-Airway (LMA) anesthetized with propofol and remifentanil delivered by Targeted-Controlled-Infusion (TCI) pumps. Women will be subjected to neurocognitive tests (GEMS, TMT A and B) the day before surgery and before hospital discharge. These test will be related to propofol and remifentanil concentrations at effector site during surgery and awakening, to BIS and Entropia values and to SPI and pupillometry values.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Montreal Cognitive Assessment test
Discover incidence of Post-Operative Cognitive decline analyzing changes in Post-Operative Cognitive Dysfunction changes between Pre-operative Global Examination of Mental Test (GEMS) test. Better neurocognitve outcome with higher scores)
Time frame
Patients will be subjected to Global Examination of Mental Test (GEMS) test one day before surgery and 1 day after surgery.2
Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Trail Making Test A and B
Discover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Trail Making Test A and B test score and post-operative Trail Making Test A and B test score. These tests will be evaluated in seconds required to be completed (better neurocognitive outcome with fewer seconds required)
Time frame
Patients will be subjected to Trail Making Test (TMT) A and B one day before surgery and 1day after surgery.3
Incidence of Post-Operative Delirium in breast-surgery patients
Discover Post-Operative Delirium submitting patients Confusion Assessment Method (CAM-ICU) test. Worse neurocognitve outcome with higher scores (ranging from 0 to 4)
Time frame
Patients will be subjected to Confusion Assessment Method (CAM) within 1 hour from awakening from anesthesia .4
Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients
Discover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Short Portable Mental Status Questionnaire score and post-operative Short Portable Mental Status Questionnaire test score. Better neurocognitve outcome with higher scores (ranging 0 to 10)
Time frame
Patients will be subjected to Short Portable Mental Status Questionnaire one day before surgery and 1 day after surgery.Sponsors and contacts
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Source ClinicalTrials.gov