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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03774420
Other study ID # MAST
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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