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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02782429
Recruitment Status : Unknown
Verified May 2016 by Flavia orange, Instituto Materno Infantil Prof. Fernando Figueira.
Recruitment status was:  Recruiting
First Posted : May 25, 2016
Last Update Posted : May 25, 2016
Sponsor:
Collaborator:
Rebeca Gonelli Albanez da Cunha Andrade
Information provided by (Responsible Party):
Flavia orange, Instituto Materno Infantil Prof. Fernando Figueira

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.

Condition or disease Intervention/treatment Phase
Delirium Inflammation Cognitive Disorders Amnestic Dementia Drug: Ketamine Other: Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Role of Ketamine in Preventing Cognitive Dysfunctions in Postoperative Period of Cardiac Surgery
Study Start Date : April 2016
Estimated Primary Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
Drug Information available for: Ketamine

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



Primary Outcome Measures :
  1. Change in cognitive disorder, defined by a drop of 2 points in the Mini-Mental State Examination [ Time Frame: Baseline and 7 days ]
  2. 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 Outcome Measures :
  1. Delirium assessed using the Confusion Assessment Method (CAM) [ Time Frame: 24 hours after surgery ]
  2. Sternotomy Pain assessed using the Visual Analogue Scale [ Time Frame: 24 hours after surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782429


Contacts
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Contact: Rebeca GA Andrade, master +55 81 988043844 bekinhagonelli@hotmail.com

Locations
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Brazil
Instituto de Medicina Integral Prof Fernando Figueira Recruiting
Recife, Pernambuco, Brazil, 50070-550
Contact: Flávia A de Orange, PhD    + 55 81 994197979    orangeflavia@gmail.com   
Contact: Rebeca GA Andrade, master    +55 81 988043844    bekinhagonelli@hotmail.com   
Sponsors and Collaborators
Flavia orange
Rebeca Gonelli Albanez da Cunha Andrade
Investigators
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Principal Investigator: Rebeca GA Andrade, master Instituto de Medicina Integral Prof Fernando Figueira

Publications of Results:
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Responsible Party: Flavia orange, Prof, Dr, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT02782429    
Other Study ID Numbers: IMIP
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016
Keywords provided by Flavia orange, Instituto Materno Infantil Prof. Fernando Figueira:
ketamine
Cardiac Surgery
Neurocognitive Disorders
Additional relevant MeSH terms:
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Delirium
Inflammation
Cognitive Dysfunction
Cognition Disorders
Pathologic Processes
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action