Clinical trial NCT03774420: Post Operative Cognitive Dysfunction After Breast Surgery
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Emergence Delirium
Post-Operative Cognitive Dysfunction
Keywords: Infusion pumps
Intraoperative brain monitoring
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women subjected to breast surgery in general anaesthesia with Laryngeal-Mask-Airway (LMA) anesthetized with propofol and remifentanil delivered by Targeted-Controlled-Infusion (TCI) pumps. Women will be subjected to neurocognitive tests (GEMS, TMT A and B) the day before surgery and before hospital discharge. These test will be related to propofol and remifentanil concentrations at effector site during surgery and awakening, to BIS and Entropia values and to SPI and pupillometry values.

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.

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

Primary outcomes:
measure: Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Montreal Cognitive Assessment test
timeFrame: Patients will be subjected to Global Examination of Mental Test (GEMS) test one day before surgery and 1 day after surgery.
measure: Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Trail Making Test A and B
timeFrame: Patients will be subjected to Trail Making Test (TMT) A and B one day before surgery and 1day after surgery.
measure: Incidence of Post-Operative Delirium in breast-surgery patients
timeFrame: Patients will be subjected to Confusion Assessment Method (CAM) within 1 hour from awakening from anesthesia .
measure: Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients
timeFrame: Patients will be subjected to Short Portable Mental Status Questionnaire one day before surgery and 1 day after surgery.
measure: Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with MiniMental State Evaluation test
timeFrame: Patients will be subjected to Confusion Assessment Method (CAM) within 1 hour from awakening from anesthesia.
measure: Incidence of Emergence Delirium in breast-surgery patients detected with 4AT test
timeFrame: Patients will be subjected to 4 AT test within 1 day from awakening from anesthesia .
Secondary outcomes:
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: Treviso Regional Hospital
state: TV
Study officials:
affiliation: University of Padova
name: Federico Linassi, MD
role: PRINCIPAL_INVESTIGATOR
References: