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

Ketamine

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.

Intervention / Treatment

  • Ketamine (DRUG)
    N/A
  • Saline (OTHER)
    N/A

Condition or Disease

  • Delirium
  • Inflammation
  • Cognitive Disorders
  • Amnestic
  • Dementia

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 50 Years and older   (Adult, Older Adult)
    Enrollment: 50 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Apr 01, 2016
    Primary Completion: May 01, 2017 ESTIMATED
    Completion Date: Aug 31, 2020
    Study First Posted: May 25, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: May 24, 2016

    Sponsors / Collaborators

    Lead Sponsor: Flavia orange
    Responsible Party: N/A

    Location

    Pernambuco, Brazil
    Recife, Pernambuco, Brazil

    Participant Groups

    • This group received ketamine in a dose 0.5 mg / in anesthesia, in addition to other drugs used for induction, which will be standardized.

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

    Eligibility Criteria

    Sex: All
    Minimum Age: 50
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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
    • Change in cognitive disorder, defined by a drop of 2 points in the Mini-Mental State Examination Baseline 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 Outcomes
    • Delirium assessed using the Confusion Assessment Method (CAM) 24 hours after surgery
    • Sternotomy Pain assessed using the Visual Analogue Scale 24 hours after surgery

    More Details

    NCT Number: NCT02782429
    Acronym: KeCoDy
    Other IDs: IMIP
    Study URL: https://clinicaltrials.gov/study/NCT02782429
    Last updated: Sep 29, 2023