Post Operative Cognitive Dysfunction After Breast Surgery

NCT03774420 | Recruiting

• 1 other identifier: MAST
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Emergence Delirium; Post-Operative Cognitive Dysfunction

Keywords

Infusion pumps; Intraoperative brain monitoring

Outcome Measures

Primary Outcomes (6)

• 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 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.

• 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 .

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Neurological pathologies
• Haemodynamical instability during surgery

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Treviso Regional Hospital

Treviso, TV, 31100, Italy

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Federico Linassi, MD

  University of Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Linassi, MD

CONTACT

049 8754256; federico.linassi@studenti.unipd.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: December 13, 2018
• Study Start: July 3, 2019
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

IT (1)