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

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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

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

Trial contacts and locations

1

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Central trial contact

Rebeca GA Andrade, master

Data sourced from clinicaltrials.gov

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