Effect of Intraoperative Dextrometomidine on Complications of the Central Nervous System in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The incidence of postoperative depression
研究概览
简要总结
With the continuous improvement of medical technology, more and more patients need to undergo surgery as a kind of treatment for their diseases. However, there are various pains that may occur in the perioperative period, risks associated with anesthesia, loss of body organs, surgical trauma, and postoperative procedures Factors such as the onset of the disease can cause the vast majority of patients to have varying degrees of emotional reactions such as worry, worry, nervousness, and fear. Emotional disorders such as depressed mood, disappointed crying, decreased mobility, and delayed thinking and cognitive function, that is, postoperative psychiatric symptoms.
Dexmedetomidine (DEX) is an alpha-2 adrenergic agonist that works by inhibiting norepinephrine. Releasing renaline, which reduces inflammation and thus plays a protective role in the central nervous system. Previous studies have shown that dexmedetomidine is lowering. DEX has the potential to prevent and treat patients undergoing cardiac surgery. The role of postoperative anxiety and depression needs to be further explored for evidence-based evidence. Based on the above research background, the hypothesis of this study is proposed. The intraoperative use of dexmedetomidine has a positive effect on alleviating postoperative anxiety and depression in patients undergoing postoperative cardiac surgery.
详细描述
- Observing the effect of intraoperative use of dexmedetomidine on the incidence of postoperative anxiety and depression in patients undergoing cardiac surgery;
- Observe the effects of intraoperative use of dexmedetomidine on postoperative delirium, quality of life, pain scores, and sleep quality in patients undergoing cardiac surgery;
- To provide a feasible plan for preventing and treating postoperative anxiety and depression in patients undergoing cardiac surgery, improve the quality of patient prognosis, and reduce the burden on society.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range from 18 to 85 years old, regardless of gender
- •Patients who undergo cardiac surgery on a scheduled basis;
- •ASA level 1-4;
- •Obtain written informed consent form;
排除标准
- •Patients with MMSE scores less than 18 or dementia, intellectual disability, and inability to communicate (coma, severe dementia, hearing or language impairment);
- •Have a history of mental or neurological disorders (such as schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis);
- •Previous history of brain injury;
- •Severe liver dysfunction (Child pugh C-grade) or renal insufficiency (preoperative dialysis);
- •Severe bradycardia (heart rate below 50 beats per minute), pathological sinus syndrome, or atrioventricular block without a pacemaker;
- •Postoperative intensive care unit (ICU) duration exceeding 7 days or death;
结局指标
主要结局
The incidence of postoperative depression
时间窗: Postoperative 7 days and 30 days
Patient Health Questionnaire-9 (PHQ-9) scale assesses depressive symptoms
次要结局
- The incidence of postoperative anxiety(Postoperative 7 days and 30 days)
- Postoperative sleep quality(Postoperative 7 days and 30 days)
- The incidence of postoperative delirium(Postoperative 7 days)
- Postoperative Pain(Postoperative 7 days and 30 days)
- Postoperative mortality rate(Postoperative 7 days and 30 days)
- Surgical related complications(Postoperative 7 days)
- Postoperative quality of life evaluation(Postoperative 30 days)
研究者
Weidong Mi
Director (Cheif expert of National key research and development program of China 2018YFC2001900)
Chinese PLA General Hospital