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

Primary Purpose

Delirium, Inflammation, Cognitive Disorders

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Ketamine
Saline
Sponsored by
Flavia orange
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring ketamine, Cardiac Surgery, Neurocognitive Disorders

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto de Medicina Integral Prof Fernando FigueiraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketamine

Placebo

Arm Description

This group received ketamine in a dose 0.5 mg / in anesthesia, in addition to other drugs used for induction, which will be standardized.

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

Outcomes

Primary Outcome Measures

Change in cognitive disorder, defined by a drop of 2 points in the Mini-Mental State Examination
Detectable levels of inflammatory biomarkers in bloodstream, such as: P-selectin (CD62p- ng/ml), CD40L soluble (ng/ml), s100B (ng/ml)

Secondary Outcome Measures

Delirium assessed using the Confusion Assessment Method (CAM)
Sternotomy Pain assessed using the Visual Analogue Scale

Full Information

First Posted
May 19, 2016
Last Updated
May 24, 2016
Sponsor
Flavia orange
Collaborators
Rebeca Gonelli Albanez da Cunha Andrade
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1. Study Identification

Unique Protocol Identification Number
NCT02782429
Brief Title
The Role of Ketamine in Preventing Cognitive Dysfunctions in Postoperative Period of Cardiac Surgery
Acronym
KeCoDy
Official Title
The Role of Ketamine in Preventing Cognitive Dysfunctions in Postoperative Period of Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Flavia orange
Collaborators
Rebeca Gonelli Albanez da Cunha Andrade

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Inflammation, Cognitive Disorders, Amnestic, Dementia
Keywords
ketamine, Cardiac Surgery, Neurocognitive Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Experimental
Arm Description
This group received ketamine in a dose 0.5 mg / in anesthesia, in addition to other drugs used for induction, which will be standardized.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group received the equivalent volume of saline, in addition to other drugs used for induction, which will be standardized.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Type
Other
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Change in cognitive disorder, defined by a drop of 2 points in the Mini-Mental State Examination
Time Frame
Baseline and 7 days
Title
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 Measure Information:
Title
Delirium assessed using the Confusion Assessment Method (CAM)
Time Frame
24 hours after surgery
Title
Sternotomy Pain assessed using the Visual Analogue Scale
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebeca GA Andrade, master
Phone
+55 81 988043844
Email
bekinhagonelli@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebeca GA Andrade, master
Organizational Affiliation
Instituto de Medicina Integral Prof Fernando Figueira
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Medicina Integral Prof Fernando Figueira
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50070-550
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flávia A de Orange, PhD
Phone
+ 55 81 994197979
Email
orangeflavia@gmail.com
First Name & Middle Initial & Last Name & Degree
Rebeca GA Andrade, master
Phone
+55 81 988043844
Email
bekinhagonelli@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
19422355
Citation
Hudetz JA, Iqbal Z, Gandhi SD, Patterson KM, Byrne AJ, Hudetz AG, Pagel PS, Warltier DC. Ketamine attenuates post-operative cognitive dysfunction after cardiac surgery. Acta Anaesthesiol Scand. 2009 Aug;53(7):864-72. doi: 10.1111/j.1399-6576.2009.01978.x. Epub 2009 Apr 28.
Results Reference
result
PubMed Identifier
22065690
Citation
Cata JP, Abdelmalak B, Farag E. Neurological biomarkers in the perioperative period. Br J Anaesth. 2011 Dec;107(6):844-58. doi: 10.1093/bja/aer338. Epub 2011 Nov 6.
Results Reference
result
PubMed Identifier
22826531
Citation
Dale O, Somogyi AA, Li Y, Sullivan T, Shavit Y. Does intraoperative ketamine attenuate inflammatory reactivity following surgery? A systematic review and meta-analysis. Anesth Analg. 2012 Oct;115(4):934-43. doi: 10.1213/ANE.0b013e3182662e30. Epub 2012 Jul 23.
Results Reference
result

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

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