Effects of Hypothermia on Delayed Neurocognitive Recovery (DNR): an Observational Trial Among Patients Undergoing Cardiac-Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Hypothermia on Delayed Neurocognitive Recovery: an Observational Trial Among Patients Undergoing Cardiac-Surgery

Conditions
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Cognitive Dysfunction, Emergence Delirium, Hypothermia

Intervention / Treatment
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* Procedure: Hypothermia during Extracorporeal Circulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hearth-valve surgery<br> | Procedure: Hypothermia during Extracorporeal Circulation<br>* Normothermia during Extracorporeal Circulation<br>|
| Hearth bypass surgery<br> | Procedure: Hypothermia during Extracorporeal Circulation<br>* Normothermia during Extracorporeal Circulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |