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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

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.

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Detailed Description

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Conditions

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Delirium Inflammation Cognitive Disorders Amnestic Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Placebo

This group received the equivalent volume of saline, in addition to other drugs used for induction, which will be standardized.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Interventions

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Ketamine

Intervention Type DRUG

Saline

Intervention Type OTHER

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No