Post Operative Cognitive Dysfunction After Breast Surgery

Recruiting

• Conditions: Post-Operative Cognitive Dysfunction; Emergence Delirium

• Registration Number: NCT03774420
• Lead Sponsor: University of Padova

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).

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 Timeline

• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-12-12
• Study First Posted: 2018-12-13
• Study Start: 2019-07-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Montreal Cognitive Assessment test	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)
Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Trail Making Test A and B	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)
Incidence of Post-Operative Delirium in breast-surgery patients	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)
Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients	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)
Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with MiniMental State Evaluation test	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.
Incidence of Emergence Delirium in breast-surgery patients detected with 4AT test	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

Trial Locations

Locations (1)

Treviso Regional Hospital; 🇮🇹 Treviso, TV, Italy