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Post Operative Cognitive Dysfunction and Delirium After Spinal Surgery

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 )

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03950557
Enrollment
200
Registered
2019-05-15
Start date
2019-07-01
Completion date
2020-12-31
Last updated
2019-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium, Post-Operative Cognitive Dysfunction

Keywords

Infusion pumps, Intraoperative brain monitoring

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.

Interventions

None listed

Sponsors

Maran Eleonora
CollaboratorUNKNOWN
University of Padova
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Neurological pathologies

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Post-Operative Cognitive Dysfunction in spinal-surgery patients detected with Montreal Cognitive Assessment testPatients 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 BPatients 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 TestPatients will be subjected to DST one day before surgery and 1 day after surgery. Better neurocognitve outcome with higher scoresDiscover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Digit Span Test score and post-operative Digit Span Test test score
Incidence of Emergence Delirium in spinal-surgery patientsPatients will be subjected to CAM 15 minutes after the awakening after general anesthesiaDiscover Emergence Delirium analyzing Post-operative Confusion Assessment Method (CAM) delivered 15 minutes after the awakening of patients

Contacts

Primary ContactFederico Linassi, MD
federico.linassi@studenti.unipd.it049 8754256

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026