Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Dichotomous outcome, a number of patients with delirium in the two study groups.
研究概览
简要总结
The objective of this study is to reduce the incidence of postoperative delirium after cardiac surgery in the elderly patient. This proposal is a clinical trial designed to reduce delirium in patients undergoing cardiac surgery by replacing standard postoperative sedation protocols (propofol, midazolam, opioids) with a new alpha2-adrenergic receptor agonist (dexmedetomidine) possessing sedative, analgesic, and antinociceptive properties. Resource utilization analysis will be performed to determine cost effectiveness of the new treatment modality.
详细描述
The proposed study will be a prospective, randomized, open label study comparing multimodal protocols for postoperative sedation after cardiac surgery. Patients will be randomly allocated to either dexmedetomidine or propofol (control) groups according to a computer generated randomization code in predetermined size blocks of four.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥60 years, undergoing high risk cardiac surgery, signed informed consent.
排除标准
- •Patients with symptomatic cerebrovascular disease, history of delirium, schizophrenia or preoperative use of psychotropic medications.
研究组 & 干预措施
Propofol
Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation
干预措施: Propofol (Drug)
Dexmedetomidine
Upon arrival to ICU patients will receive dexmedetomidine bolus of 0.4mcg/kg followed by an infusion of 0.2-0.7mcg/kg per hour for a maximum period of 24 hours.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Dichotomous outcome, a number of patients with delirium in the two study groups.
时间窗: up to 7 days postoperatively or discharge
Assessment of delirium will be performed utilizing the CAM-ICU
次要结局
- The total cost for each patient(Up to 7 days or discharge)