Post Operative Cognitive Dysfunction and Delirium After Spinal Surgery

NCT ID: NCT03950557

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-12-31

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.

Conditions

Emergence Delirium; Post-Operative Cognitive Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Neurological pathologies

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maran Eleonora

UNKNOWN

Sponsor Role: collaborator

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Federico Linassi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Federico Linassi, MD

Role: CONTACT

federico.linassi@studenti.unipd.it

049 8754256

Other Identifiers

FLUO

Identifier Type: -

Identifier Source: org_study_id