Clinical trial NCT02782429: The Role of Ketamine in Preventing Cognitive Dysfunctions in Postoperative Period of Cardiac Surgery
Official title: The Role of Ketamine in Preventing Cognitive Dysfunctions in Postoperative Period of Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Delirium
Inflammation
Cognitive Disorders
Amnestic
Dementia
Keywords: ketamine
Cardiac Surgery
Neurocognitive Disorders
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
Collaborators: name: Rebeca Gonelli Albanez da Cunha Andrade
First posted: 2016-05-25
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Change in cognitive disorder, defined by a drop of 2 points in the Mini-Mental State Examination
timeFrame: Baseline and 7 days
measure: Detectable levels of inflammatory biomarkers in bloodstream, such as: P-selectin (CD62p- ng/ml), CD40L soluble (ng/ml), s100B (ng/ml)
timeFrame: Change from baseline at 6 hours and 24 hours after surgery
Secondary outcomes:
measure: Delirium assessed using the Confusion Assessment Method (CAM)
timeFrame: 24 hours after surgery
measure: Sternotomy Pain assessed using the Visual Analogue Scale
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Instituto de Medicina Integral Prof Fernando Figueira
state: Pernambuco
Study officials:
affiliation: Instituto de Medicina Integral Prof Fernando Figueira
name: Rebeca GA Andrade, master
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.