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Recruiting NCT03774420

Post Operative Cognitive Dysfunction After Breast Surgery

— Observational Emergence Delirium Post-Operative Cognitive Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Emergence Delirium, Post-Operative Cognitive Dysfunction. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Post-Operative Cognitive Dysfunction After Breast Surgery: Incidence and Relation With Common Intraoperative Neuromonitoring Data and Concentration of Propofol and Remifentanil Infused With Targeted Controlled Infusion (TCI )in Women With Laryngeal Mask Airway

Overview

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).

Detailed description

Post-Operative Cognitive Dysfunction has not been yet investigated after general anaesthesia with Targeted-Controlled-Infusion (TCI) and Laryngeal-Mask-Airway (LMA), daily used in the investigator's Hospital to anesthetize women undergoing breast surgery. Aim of this trial is to define if neurocognitive tests (Montreal Cognitive Assessment, Trail Making Test A and B, Digit Span Test) before and after surgery, and CAM for Postoperative Delirium relate to concentrations at effector's site (Ce) of propofol and remifentanil TCI and the values of Bispectral Index and Entropy monitoring and Surgical Plethysmographic Index (SPI), as well as to Pupillometry values.

Primary outcome measures

  • Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Montreal Cognitive Assessment test [Time frame: Patients will be subjected to Global Examination of Mental Test (GEMS) test one day before surgery and 1 day after surgery.]
  • Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Trail Making Test A and B [Time frame: Patients will be subjected to Trail Making Test (TMT) A and B one day before surgery and 1day after surgery.]
  • Incidence of Post-Operative Delirium in breast-surgery patients [Time frame: Patients will be subjected to Confusion Assessment Method (CAM) within 1 hour from awakening from anesthesia .]
  • Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients [Time frame: Patients will be subjected to Short Portable Mental Status Questionnaire one day before surgery and 1 day after surgery.]
  • Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with MiniMental State Evaluation test [Time frame: Patients will be subjected to Confusion Assessment Method (CAM) within 1 hour from awakening from anesthesia.]
  • Incidence of Emergence Delirium in breast-surgery patients detected with 4AT test [Time frame: Patients will be subjected to 4 AT test within 1 day from awakening from anesthesia .]

Eligibility criteria

Inclusion criteria

  • General Anaesthesia delivered with Propofol and Remifentanil with Targeted Controlled Infusion
  • Use of Laryngeal Mask airway

Exclusion criteria

  • Neurological pathologies
  • Haemodynamical instability during surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Treviso Regional Hospital — Treviso

Identifiers

NCT: NCT03774420 · MAST

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗