Post Operative Cognitive Dysfunction After Breast Surgery

NCT ID: NCT03774420

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-03
• Study Completion Date: 2025-12-31

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.

Conditions

Emergence Delirium; Post-Operative Cognitive Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Federico Linassi

MD, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Federico Linassi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Locations

Treviso Regional Hospital

Treviso, TV, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Federico Linassi, MD

Role: CONTACT

federico.linassi@studenti.unipd.it

049 8754256

Facility Contacts

Federico Linassi

Role: primary

linus889@icloud.com

Other Identifiers

MAST

Identifier Type: -

Identifier Source: org_study_id