The Role of Ketamine in Preventing Cognitive Dysfunctions in Postoperative Period of Cardiac Surgery

Study Overview
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Brief Summary
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The purpose of this study is to analyze the Ketamine with its anti-inflammatory profile would be able to prevent cognitive disorders in the postoperative period of cardiac surgery, since these disorders contribute to an impact on morbidity / mortality in this population.

Official Title
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The Role of Ketamine in Preventing Cognitive Dysfunctions in Postoperative Period of Cardiac Surgery

Conditions
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Delirium, Inflammation, Cognitive Disorders, Amnestic, Dementia

Intervention / Treatment
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* Drug: Ketamine
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged over 50 years. Be submitted to cardiac surgery by sternotomy and with the use of cardiopulmonary bypass (CPB). American Society of Anesthesiologists classification 1, 2,3 and 4. Exclusion Criteria: Patients undergoing reoperation. Patients undergoing heart transplantation. Patients using vasopressor agents and / or ionotropic continuous preoperatively. Patients with prior endotracheal intubation and consequently Ventilatory Assistance Mechanics. Patients with documented psychiatric disorders. Patients with previous cognitive disorders. Patients with a history of alcohol or drug abuse. Patients with a history of cerebrovascular accident (CVA) with less than 3 months.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine<br>This group received ketamine in a dose 0.5 mg / in anesthesia, in addition to other drugs used for induction, which will be standardized. | Drug: Ketamine<br> <br> |
| Placebo Comparator: Placebo<br>This group received the equivalent volume of saline, in addition to other drugs used for induction, which will be standardized. | Other: Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive disorder, defined by a drop of 2 points in the Mini-Mental State Examination |  | Baseline and 7 days | 
| Detectable levels of inflammatory biomarkers in bloodstream, such as: P-selectin (CD62p- ng/ml), CD40L soluble (ng/ml), s100B (ng/ml) |  | Change from baseline at 6 hours and 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium assessed using the Confusion Assessment Method (CAM) |  | 24 hours after surgery | 
| Sternotomy Pain assessed using the Visual Analogue Scale |  | 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketamine, Cardiac Surgery, Neurocognitive Disorders