Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting: A Randomized Double-Blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Percent of delirium treatment
研究概览
简要总结
The aim of this study is to determine the effect of pregabalin versus dexmedetomidine on the treatment and lasting duration of delirium in fast tracking elderly patients after Coronary Artery Bypass Grafting.
详细描述
Delirium is an acute brain disorder that involves changes in consciousness, attention, cognition, and perception.The incidence of postoperative delirium (POD) is high among patients undergoing cardiac surgery, ranging from 20 to 50%, and the risk is even higher in the elderly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CABG patients ≥ 65 years of age both genders American Society of Anesthesiologists (ASA) physical status classification II or III planned for fast track developed postoperative delirium (POD).
排除标准
- •Patients who had history of psychiatric diseases; inability to communicate;
- •previous history of POD; preoperative sick sinus syndrome, allergy/sensitivity to pregabalin or dexmedetomidine, severe bradycardia (heart rate <50 beat per minute), second-degree or above atrioventricular block without pacemaker; severe hepatic or renal insufficiency.
- •Previous cardiac or thoracic surgery, known diagnosis of depression or other major psychiatric diseases, cognitive impairment or inability to cooperate with the study, renal insufficiency, and history of substance abuse.
研究组 & 干预措施
Pregabalin group
Patients will receive pregabalin capsules (75 mg) every 12 h for 24 hours by nasogastric tube.
干预措施: Pregabalin (Drug)
Dexmedetomidine group
Patients will receive a bolus dose of 0.4 μg/kg dexmedetomidine (over a period of 10 to 20 min) followed by an infusion of 0.2 to 0.7 μg/h.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Percent of delirium treatment
时间窗: 24 hour postoperatively
Assessment of delirium will be performed preoperatively and postoperatively at 12-h intervals or as needed according to the patient's condition using the confusion assessment method (CAM)
次要结局
- Level of sedation(24 hour postoperatively)
- Length of hospital stay(1 month postoperatively)
- Incidence of weaning from mechanical ventilation(1 week postoperatively)
研究者
Islam Morsy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
Tanta University