Post Operative Cognitive Dysfunction After Breast Surgery

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

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).

Study Overview

• Status: Recruiting
• Conditions: Emergence Delirium; Post-Operative Cognitive Dysfunction

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Federico Linassi, MD; Phone Number: 049 8754256; Email: federico.linassi@studenti.unipd.it

Study Locations

• Italy
  • TV
    • Treviso, TV, Italy, 31100
      • Recruiting
      • Treviso Regional Hospital
      • Contact: Federico Linassi; Email: linus889@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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 MiniMental State Evaluation test	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.	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	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	Patients will be subjected to 4 AT test within 1 day from awakening from anesthesia .
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)	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	Discover Post-Operative Delirium submitting patients Confusion Assessment Method (CAM-ICU) test. Worse neurocognitve outcome with higher scores (ranging from 0 to 4)	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	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)	Patients will be subjected to Short Portable Mental Status Questionnaire one day before surgery and 1 day after surgery.

Collaborators and Investigators

• Sponsor: University of Padova
• Investigators: Principal Investigator: Federico Linassi, MD, University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2019
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: December 12, 2018
• First Posted (Actual): December 13, 2018

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Infusion pumps; Intraoperative brain monitoring
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium
• Other Study ID Numbers: MAST

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No