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NCT Number: NCT03774420

Post Operative Cognitive Dysfunction After Breast Surgery

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).

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Key information

Conditions

Emergence Delirium Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Post-operative Cognitive Dysfunction Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Treviso Regional Hospital

Treviso, TV, 31100, Italy

Location status: Recruiting

Location contact

Federico Linassi

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    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)

  2. 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.

    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)

  3. 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 .

    Discover Post-Operative Delirium submitting patients Confusion Assessment Method (CAM-ICU) test. Worse neurocognitve outcome with higher scores (ranging from 0 to 4)

  4. 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.

    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)

  5. 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.

    Discover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Mini Mental State Evaluation test and postoperative Mini Mental State Evaluation test score. Worse eurocongitive outcome with lower scores.

  6. 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 .

    Discover Post-Operative Cognitive Dysfunction analyzing acute changes in postoperative congition function utilizing the 4AT test. Worse neurocognitve outcome with higher scores. Worse neurocognitve outcome with higher scores

Study contacts

Contact information is provided by the study sponsor or research team.

Federico Linassi, MD

CONTACT

[email protected]

049 8754256

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Dec 13, 2018
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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