Post Operative Cognitive Dysfunction and Delirium After Spinal Surgery

NCT03950557 | Unknown

• 1 other identifier: FLUO
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Emergence Delirium; Post-Operative Cognitive Dysfunction

Keywords

Infusion pumps; Intraoperative brain monitoring

Outcome Measures

Primary Outcomes (5)

• Incidence of Post-Operative Cognitive Dysfunction in spinal-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)

• Incidence of Post-Operative Cognitive Dysfunction in spinal-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)

• Incidence of Post-Operative Cognitive Dysfunction in spinal-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

• Incidence of Emergence Delirium in spinal-surgery patients

  Discover Emergence Delirium analyzing Post-operative Confusion Assessment Method (CAM) delivered 15 minutes after the awakening of patients

  Patients will be subjected to CAM 15 minutes after the awakening after general anesthesia

• Incidence of Emergence Delirium in spinal-surgery patients

  Discover Emergence Delirium analyzing Post-operative Confusion Assessment Method (CAM) delivered 60 minutes after the awakening of patients

  Patients will be subjected to CAM 60 minutes after the awakening after general anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Neurological pathologies

Sponsors & Collaborators

• University of Padova: lead
• Maran Eleonora: collaborator

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Federico Linassi, MD

CONTACT

049 8754256; federico.linassi@studenti.unipd.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 15, 2019
• Study Start: July 1, 2019
• Primary Completion: October 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share