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

Flavia orange

Status and phase: Unknown; Phase 4

Conditions: Inflammation; Delirium; Dementia; Amnestic; Cognitive Disorders

Treatments: Other: Saline; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02782429

IMIP

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 2 patient groups, including a placebo group

Ketamine

Experimental group

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.

Treatment:

Drug: Ketamine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Saline