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

Phase 4

• Conditions: Cognitive Disorders; Amnestic; Delirium; Inflammation; Dementia
• Interventions: Other: Saline; Drug: Ketamine

• Registration Number: NCT02782429
• Lead Sponsor: Flavia orange

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-04
• Status Verified: 2016-05
• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-05-24
• Last Update Submitted: 2016-05-24
• Study First Posted: 2016-05-25
• Last Update Posted: 2016-05-25
• Primary Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	This group received the equivalent volume of saline, in addition to other drugs used for induction, which will be standardized.
Ketamine	Ketamine	This group received ketamine in a dose 0.5 mg / in anesthesia, in addition to other drugs used for induction, which will be standardized.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Delirium assessed using the Confusion Assessment Method (CAM)	24 hours after surgery
Sternotomy Pain assessed using the Visual Analogue Scale	24 hours after surgery

Trial Locations

Locations (1)

Instituto de Medicina Integral Prof Fernando Figueira; 🇧🇷 Recife, Pernambuco, Brazil