Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-24 @ 12:28 PM
Study NCT ID:
NCT03774420
Status:
RECRUITING
Last Update Posted:
2025-03-17
First Post:
2018-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Operative Cognitive Dysfunction After Breast Surgery
Sponsor:
University of Padova
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: