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

May 24, 2016 updated by: Flavia orange
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50070-550
        • Recruiting
        • Instituto de Medicina Integral Prof Fernando Figueira
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Ketamine
Placebo Comparator: Placebo
This group received the equivalent volume of saline, in addition to other drugs used for induction, which will be standardized.
Other: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in cognitive disorder, defined by a drop of 2 points in the Mini-Mental State Examination
Time Frame: Baseline and 7 days
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
Change from baseline at 6 hours and 24 hours after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Flavia orange

Collaborators

Rebeca Gonelli Albanez da Cunha Andrade

Investigators

  • Principal Investigator: Rebeca GA Andrade, master, Instituto de Medicina Integral Prof Fernando Figueira

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

May 19, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimate)

May 25, 2016

Study Record Updates

Last Update Posted (Estimate)

May 25, 2016

Last Update Submitted That Met QC Criteria

May 24, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMIP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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