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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02782429
Acronym
KeCoDy
Enrollment
50
Registered
2016-05-25
Start date
2016-04-30
Completion date
Unknown
Last updated
2016-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amnestic, Cognitive Disorders, Delirium, Dementia, Inflammation

Keywords

ketamine, Cardiac Surgery, Neurocognitive Disorders

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.

Interventions

DRUGKetamine
OTHERSaline

Sponsors

Rebeca Gonelli Albanez da Cunha Andrade
CollaboratorUNKNOWN
Flavia orange
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change in cognitive disorder, defined by a drop of 2 points in the Mini-Mental State ExaminationBaseline 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

MeasureTime frame
Delirium assessed using the Confusion Assessment Method (CAM)24 hours after surgery
Sternotomy Pain assessed using the Visual Analogue Scale24 hours after surgery

Countries

Brazil

Contacts

Primary ContactRebeca GA Andrade, master
bekinhagonelli@hotmail.com+55 81 988043844

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026