Post Operative Cognitive Dysfunction After Breast Surgery

Emergence Delirium Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03774420
• Other study ID #: MAST
• Status: Recruiting
• Start date: July 3, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University of Padova
• Contact: Federico Linassi, MD
• Phone: 049 8754256
• Email: federico.linassi[@]studenti.unipd.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aim of this trial is to define if Post-Operative Cognitive Dysfunction, detected analyzing changes between pre-operative and post-operative Neurocognitive Test, relate to concentration of effector's site concentration of propofol and remifentanil TCI and to the common intraoperative neuromonitoring values.

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 relate to concentrations at effector's site (Ec) of propofol and remifentanil TCI and the values of Bispectral Index and Entropy monitoring and Surgical Plethysmographic Index (SPI).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Emergence Delirium
• Post-Operative Cognitive Dysfunction
• Postoperative Cognitive Complications

Locations

Country	Name	City	State
Italy	Treviso Regional Hospital	Treviso	TV

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Montreal Cognitive Assessment test score and post-operative Montreal Cognitive Assessment test score	Patients will be subjected to Montreael Cognitive Assessment (MOCA) test one day before surgery and 1 day after surgery. This test has a score ranging from 1 (minimum) to 30 (maximum). Better neurocognitve outcome with higher scores)
Primary	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	Patients will be subjected to Trail Making Test (TMT) A and B one day before surgery and 1day after surgery. These tests will be evaluated in seconds required to be completed (better neurocognitive outcome with fewer seconds required)
Primary	Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Digit Span Test	Discover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Digit Span Test score and post-operative Digit Span Test test score	Patients will be subjected to DST one day before surgery and 1 day after surgery. Better neurocognitve outcome with higher scores
Primary	Incidence of Post-Operative Delirium in breast-surgery patients	Discover Post-Operative Delirium submitting patients Confusion Assessment Method (CAM-ICU) test	Patients will be subjected to CAM-ICU 15 minutes after awakening from anaesthesia. This test can be positive (Delirium present) or negative (Delirium absent)
Primary	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	Patients will be subjected to Short Portable Mental Status Questionnaire one day before surgery and 1 day after surgery. Better neurocognitve outcome with lower scores