A Comparative Evaluation of Dexmedetomidine and Midazolam ınfusions With Respect to Postoperative Delirium in Patients Undergoing Coronary Artery Bypass Grafting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Delirium
研究概览
简要总结
The aim is to compare the incidence of postoperative delirium following coronary artery bypass grafting (CABG) between patients receiving dexmedetomidine and those receiving midazolam infusions.
详细描述
Patients will be allocated into two groups. Those receiving intraoperative dexmedetomidine infusion will constitute Group D (n = 30), while those receiving intraoperative midazolam infusion will constitute Group M (n = 30). Demographic data, including age, sex, and body mass index, will be recorded.
Intraoperative heart rate, mean arterial pressure, peripheral oxygen saturation (SpO₂), bispectral index (BIS), and cerebral oxygenation (RSO₂) values will be documented at predetermined intervals. Changes in partial carbondioxide pressure (pCO₂) levels will also be recorded. Surgical duration, cardiopulmonary bypass time, recovery time, length of intensive care unit stay, and the presence of delirium as assessed by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) will be documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients scheduled for elective coronary artery bypass graft surgery.
排除标准
- •Patients with renal disorders,
- •Patients with hepatic disorders,
- •Patients with neuropsychiatric disorders,
- •Patients whom informed consent could not be obtained
- •Patients who declined to participate in the study.
研究组 & 干预措施
Midazolam
Following the induction of standard general anaesthesia, midazolam will be administered as a continuous intravenous infusion at a dose of 0.03-0.06 mg/kg/h.
干预措施: intravenous midazolam infusion + Standard anesthesia (Drug)
Dexmedetomidine
Following the induction of standard general anaesthesia, dexmedetomidine will be administered as a continuous intravenous infusion at a dose of 0.3-0.7 µg/kg/h.
干预措施: Intravenous Dexmedetomidine infusion + Standard Anesthesia (Drug)
结局指标
主要结局
Delirium
时间窗: Postoperative 24 hours
Presence of delirium according to the CAM-ICU assessment
次要结局
未报告次要终点
研究者
Oguz Gundogdu
Associate professor
Cumhuriyet University