The Role of Ketamine in Preventing Cognitive Dysfunctions in Postoperative Period of Cardiac Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in cognitive disorder, defined by a drop of 2 points in the Mini-Mental State Examination
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Ketamine
This group received ketamine in a dose 0.5 mg / in anesthesia, in addition to other drugs used for induction, which will be standardized.
干预措施: Ketamine (Drug)
Placebo
This group received the equivalent volume of saline, in addition to other drugs used for induction, which will be standardized.
干预措施: Saline (Other)
结局指标
主要结局
Change in cognitive disorder, defined by a drop of 2 points in the Mini-Mental State Examination
时间窗: 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)
时间窗: Change from baseline at 6 hours and 24 hours after surgery
次要结局
- Delirium assessed using the Confusion Assessment Method (CAM)(24 hours after surgery)
- Sternotomy Pain assessed using the Visual Analogue Scale(24 hours after surgery)
研究者
Flavia orange
Prof, Dr
Instituto Materno Infantil Prof. Fernando Figueira