The Role of Ketamine in Preventing Cognitive Dysfunctions in Postoperative Period of Cardiac Surgery (NCT02782429) | Clinical Trial Compass
UnknownPhase 4
The Role of Ketamine in Preventing Cognitive Dysfunctions in Postoperative Period of Cardiac Surgery
Brazil50 participantsStarted 2016-04
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in cognitive disorder, defined by a drop of 2 points in the Mini-Mental State Examination
Timeframe: Baseline and 7 days
2
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