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Clinical Trials/NCT03950557
NCT03950557
Unknown
Not Applicable

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 )

University of Padova0 sites200 target enrollmentJuly 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emergence Delirium
Sponsor
University of Padova
Enrollment
200
Primary Endpoint
Incidence of Emergence Delirium in spinal-surgery patients
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
December 31, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Padova
Responsible Party
Principal Investigator
Principal Investigator

Federico Linassi

Principal Investigator

University of Padova

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Neurological pathologies

Outcomes

Primary Outcomes

Incidence of Emergence Delirium in spinal-surgery patients

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

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

Incidence of Post-Operative Cognitive Dysfunction in spinal-surgery patients detected with Montreal Cognitive Assessment test

Time Frame: 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)

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

Incidence of Post-Operative Cognitive Dysfunction in spinal-surgery patients detected with Trail Making Test A and B

Time Frame: 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)

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

Incidence of Post-Operative Cognitive Dysfunction in spinal-surgery patients detected with Digit Span Test

Time Frame: Patients will be subjected to DST one day before surgery and 1 day after surgery. Better neurocognitve outcome with higher scores

Discover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Digit Span Test score and post-operative Digit Span Test test score

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