Post Operative Cognitive Dysfunction and Delirium After Spinal Surgery

Emergence Delirium Clinical Trial

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 )

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03950557
• Other study ID #: FLUO
• Status: Not yet recruiting
• Start date: July 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2019
• Source: University of Padua
• Contact: Federico Linassi, MD
• Phone: 049 8754256
• Email: federico.linassi[@]studenti.unipd.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• General Anaesthesia delivered with Propofol and Remifentanil with Targeted Controlled Infusion

• Surgical duration > 60 minutes

Exclusion Criteria:

• Neurological pathologies

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delirium
• Emergence Delirium
• Post-Operative Cognitive Dysfunction

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Padua	Maran Eleonora

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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