NCT02782429

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Last Updated

May 25, 2016

Status Verified

May 1, 2016

Enrollment Period

1.1 years

First QC Date

May 19, 2016

Last Update Submit

May 24, 2016

Conditions

DeliriumInflammationCognitive DisordersAmnesticDementia

Keywords

ketamineCardiac SurgeryNeurocognitive Disorders

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Delirium assessed using the Confusion Assessment Method (CAM)

    24 hours after surgery

  • Sternotomy Pain assessed using the Visual Analogue Scale

    24 hours after surgery

Study Arms (2)

Ketamine

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Other: Saline

Interventions

KetamineDRUG
Ketamine
SalineOTHER
Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Medicina Integral Prof Fernando Figueira

Recife, Pernambuco, 50070-550, Brazil

RECRUITING

Related Publications (3)

  • 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.

    PMID: 19422355RESULT

  • 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.

    PMID: 22065690RESULT

  • 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.

    PMID: 22826531RESULT

MeSH Terms

Conditions

DeliriumInflammationCognitive DysfunctionDementiaNeurocognitive Disorders

Interventions

KetamineSodium Chloride

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersPathologic ProcessesCognition DisordersBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Rebeca GA Andrade, master

    Instituto de Medicina Integral Prof Fernando Figueira

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebeca GA Andrade, master

CONTACT

+55 81 988043844bekinhagonelli@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof, Dr

Study Record Dates

First Submitted

May 19, 2016

First Posted

May 25, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2017

Last Updated

May 25, 2016

Record last verified: 2016-05

Locations

BR(1)