Clinical trial NCT03950557: Post Operative Cognitive Dysfunction and Delirium After Spinal Surgery
Official title: Post-Operative Cognitive Dysfunction and Delirium After Spinal Surgery: Incidence and Relation With Common Intraoperative Neuromonitoring Data, Blood Pressure Parameters and Concentration of Propofol and Remifentanil Infused With Targeted Controlled Infusion (TCI )
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emergence Delirium
Post-Operative Cognitive Dysfunction
Keywords: Infusion pumps
Intraoperative brain monitoring
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: Maran Eleonora
First posted: 2019-05-15
Enrollment: 200
Sex: ALL
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: Patients subjected to spinal surgery in general anaesthesia anesthetized with propofol and remifentanil delivered by Targeted-Controlled-Infusion (TCI) pumps. Women will be subjected to neurocognitive tests (MOCA, TMT A and B, DST, Pfeiffer, CAM) the day before surgery, 15 and 60 minutes after awakening (only CAM) and on the first post-operative day. These test will be related to propofol and remifentanil concentrations at effector site during surgery and awakening, to BIS and Entropia values and to intraoperative blood pressure values.

Brief summary: Aim of this trial is to define if Post-Operative Cognitive Dysfunction and Delirium, 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.

Detailed description: Post-Operative Cognitive Dysfunction and Emergence Delirium has not been yet investigated after general anaesthesia with Targeted-Controlled-Infusion (TCI), daily used in the investigator's Hospital to anesthetize patients undergoing spinal surgery. Aim of this trial is to define if neurocognitive tests (Pfeiffer test, Montreal Cognitive Assessment, Trail Making Test A and B, Digit Span Test, Confusion Assessment Method) before and after surgery relate to concentrations at effector's site (Ec) of propofol and remifentanil TCI, the values of Bispectral Index, blood pressure values and usage of drugs to increase arterial blood pressure.

Eligibility criteria: Inclusion Criteria:

* General Anaesthesia delivered with Propofol and Remifentanil with Targeted Controlled Infusion
* Surgical duration \> 60 minutes

Exclusion Criteria:

* Neurological pathologies

Primary outcomes:
measure: Incidence of Post-Operative Cognitive Dysfunction in spinal-surgery patients detected with Montreal Cognitive Assessment test
timeFrame: 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)
measure: Incidence of Post-Operative Cognitive Dysfunction in spinal-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. These tests will be evaluated in seconds required to be completed (better neurocognitive outcome with fewer seconds required)
measure: Incidence of Post-Operative Cognitive Dysfunction in spinal-surgery patients detected with Digit Span Test
timeFrame: Patients will be subjected to DST one day before surgery and 1 day after surgery. Better neurocognitve outcome with higher scores
measure: Incidence of Emergence Delirium in spinal-surgery patients
timeFrame: Patients will be subjected to CAM 15 minutes after the awakening after general anesthesia
measure: Incidence of Emergence Delirium in spinal-surgery patients
timeFrame: Patients will be subjected to CAM 60 minutes after the awakening after general anesthesia
Secondary outcomes:
Other outcomes:
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