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

Flavia orange50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Delirium Inflammation Cognitive Disorders Amnestic Dementia

Interventions

KetamineDRUG

SalineOTHER

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Instituto de Medicina Integral Prof Fernando Figueira

Recife, Pernambuco, Brazil

RECRUITING

Outcomes

Primary Outcomes

Change in cognitive disorder, defined by a drop of 2 points in the Mini-Mental State Examination

Time frame: 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)

Time frame: Change from baseline at 6 hours and 24 hours after surgery

Secondary Outcomes

Delirium assessed using the Confusion Assessment Method (CAM)

Time frame: 24 hours after surgery

Sternotomy Pain assessed using the Visual Analogue Scale

Time frame: 24 hours after surgery

Central Contacts

Rebeca GA Andrade, master

CONTACT

+55 81 988043844 bekinhagonelli@hotmail.com

Data from ClinicalTrials.gov

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