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

Dementia Clinical Trial

— KeCoDy  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02782429
• Other study ID #: IMIP
• Status: Recruiting
• Phase: Phase 4
• First received: May 19, 2016
• Last updated: May 24, 2016
• Start date: April 2016

Study information

• Verified date: May 2016
• Source: Instituto Materno Infantil Prof. Fernando Figueira
• Contact: Rebeca GA Andrade, master
• Phone: +55 81 988043844
• Email: bekinhagonelli[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Amnestic
• Cognition Disorders
• Cognitive Disorders
• Delirium
• Dementia
• Inflammation

Intervention

Drug:
• Ketamine

Other:
• Saline

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Integral Prof Fernando Figueira	Recife	Pernambuco

Sponsors (2)

Lead Sponsor	Collaborator
Flavia orange	Rebeca Gonelli Albanez da Cunha Andrade

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. Review. — View 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. Epub 2012 Jul 23. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive disorder, defined by a drop of 2 points in the Mini-Mental State Examination		Baseline and 7 days	Yes
Primary	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	Yes
Secondary	Delirium assessed using the Confusion Assessment Method (CAM)		24 hours after surgery	Yes
Secondary	Sternotomy Pain assessed using the Visual Analogue Scale		24 hours after surgery	Yes