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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03636074
Other study ID # Zivago
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 7, 2020
Est. completion date June 12, 2023

Study information

Verified date November 2023
Source University of Padova
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Post-operative cognitive dysfunction is a common disease in patient undergoing general anaesthesia, especially in older patients. No correlations have been yet studied between intraoperative hypothermia and incidence of Delayed Neurocognitive Recovery. Investigators are going to estimate the Relative Risk of Hypothermia and emergence of Post-operative cognitive dysfunction in cardiac-surgery patients.


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date June 12, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Adults patients undergoing Cardiac - Surgery intervention with extracorporeal circulation Exclusion Criteria: - Neurological disease before surgery - Sedation in Cardiac-Surgery Intensive Unit > 6 hours - Cerebral regional Oxygen saturation <20% baseline during surgery

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Hypothermia during Extracorporeal Circulation
Normothermia during Extracorporeal Circulation

Locations

Country Name City State
Italy Università degli Studi di Padova Padova PD

Sponsors (1)

Lead Sponsor Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery Discover changes between pre-operative general cognition tests (Montreal Cognitive Assessment and Short Portable Mental Status Questionnaire) test score and post-operative Montreal Cognitive Assessment test score. Patients will be subjected to Montreal Cognitive Assessment and Short Portable Mental Status Questionnaire test one day before surgery and 4-6 days after surgery
Primary Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery Discover changes between pre-operative Trail Making Test A and B score and post-operative Trail Making Test A and B score. Patients will be subjected to Trail Making Test A and B one day before surgery and 4-6 days after surgery
Primary Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery Discover changes between pre-operative Digit Span Test score and post-operative Digit Span Test score. Patients will be subjected to Digit Span Test one day before surgery and 4-6 days after surgery
Primary Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery Discover changes between pre-operative Frontal Assessment Battery test score and post-operative Frontal Assessment Battery test score and Patients will be subjected to Frontal Assessment Battery test one day before surgery and 4-6 days after surgery
Secondary Effects of hypothermia during Extracorporeal Circulation in Cardiac Surgery Discover statistical significance difference in incidence of Post-Operative Cognitive Decline between patients undergoing normothermia and patients undergoing hypothermia during Extracorporeal Circulation in Cardiac Surgery One day before surgery and 4-6 days after surgery patients will be subjected to cognitive test to diagnosticate Post-Operative Cognitive Decline
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