Effect of Low-dose Dexmedetomidine on Postoperative Delirium in Patients After Cardiac Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 502
- 试验地点
- 2
- 主要终点
- Incidence of delirium within the first 5 days after surgery
研究概览
简要总结
Delirium is an acutely occurred and fluctuating cerebral dysfunction characterized with inattention, altered consciousness, cognitive decline and/or abnormal perception. It is common in the elderly after cardiac surgery and is associated with worse outcomes. Causes leading to delirium are multifactorial but sleep disturbances remains an important one. In previous studies, sedative-dose dexmedetomidine improves sleep quality in ICU patients with mechanical ventilation; and low-dose dexmedetomidine improves sleep quality in postoperative patients without mechanical ventilation. In recent studies of elderly after noncardiac surgery, night-time infusion of low-dose dexmedetomidine reduces delirium and improves 2-year survival. The investigators hypothesize that, for elderly patients after cardiac surgery, night-time infusion of dexmedetomidine may also improve sleep quality, reduce delirium development and improve 2-year survival.
详细描述
Delirium is an acutely occurred and fluctuating cerebral dysfunction characterized with inattention, altered consciousness, cognitive decline and/or abnormal perception. It is common in the elderly after cardiac surgery and is associated with worse outcomes.
The development of delirium is a consequence of multiple factors. For patients undergoing cardiac surgery, surgical stress and/or cardiopulmonary bypass can produce hyper-inflammatory and stress response, both of which are important factors leading to delirium. Meanwhile, patients in ICU after major surgery often develop sleep disturbances, which are also associated with increased risk of delirium.
Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, analgesic and anxiolytic properties. In previous studies of elderly patients admitted to ICU after non-cardiac surgery, continuous infusion of low-dose dexmedetomidine during nighttime improves sleep quality, reduces delirium, and improves 2-year survival.
The investigators hypothesize that, for patients admitted to ICU after cardiac surgery, nighttime infusion of low-dose dexmedetomidine can decrease the incidence of delirium and improve long-term survival. The purpose of this study is to investigate the effect of nighttime infusion of low-dose dexmedetomidine on postoperative sleep quality, delirium, and 2-year survival in elderly patients admitted to ICU after cardiac surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥60 years but <90 years;
- •Scheduled to undergo cardiac surgery with cardiopulmonary bypass under general anesthesia;
- •Expected to stay in the intensive care unit (ICU) for at least 1 night after surgery.
排除标准
- •Patients who meet any of the following criteria will be excluded.
- •Refuse to participate in the study;
- •Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
- •Preoperative obstructive sleep apnea (previously diagnosed as obstructive sleep apnea, or the snoring, tiredness, observed apnea, high blood pressure-body mass index, age, neck circumference and gender [STOP-Bang] questionnaires ≥3);
- •Inability to communicate during the preoperative period because of coma, profound dementia or language barrier;
- •Preoperative sick sinus syndrome, severe sinus bradycardia (< 50 beats per minute), or second-degree atrioventricular block or above without pacemaker;
- •Severe hepatic dysfunction (Child-Pugh class C);
- •Severe renal dysfunction (requirement of renal replacement therapy) before surgery;
- •Presence of delirium (diagnosed by the Confusion Assessment Method [CAM]/CAM for the Intensive Care Unit [CAM-ICU]);
- •Current treatment with dexmedetomidine or clonidine.
研究组 & 干预措施
Dexmedetomidine group
Dexmedetomidine infusion is administered from 16:00 to 08:00 during the night of surgery; and will repeated for a maximum of 5 consecutive nights. For patients with mechanical ventilation, the infusion rate is 0.2-0.7 ug/kg/h; for those without mechanical ventilation, the infusion rate is 0.05-0.2 ug/kg/h. The target depth of sedation is Richmond Agitation-Sedation Scale (RASS) -1.
干预措施: Dexmedetomidine (Drug)
Placebo group
Placebo (normal saline) infusion is administered from 16:00 to 08:00 in the same speed for the same duration as in the dexmedetomidine group. The conventional sedation is provided when necessary with propofol and/or midazolam by intravenous infusion/injection. The target depth of sedation depth is RASS -1.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of delirium within the first 5 days after surgery
时间窗: During the first 5 days after surgery
Delirium is assessed twice daily (8:00-10:00 am, 18:00-20:00 pm) with the Confusion Assessment Method (CAM, for patients without mechanical ventilation) or CAM for the intensive care unit (CAM-ICU, for patients with mechanical ventilation) during postoperative days 1-5.
次要结局
- Duration of mechanical ventilation after surgery(Up to 30 days after surgery)
- Length of stay in hospital after surgery(Up to 30 days after surgery)
- All-cause 30-day mortality(At 30 days after surgery)
- Subjective sleep quality at 30 days after surgery(At 30 days after surgery)
- Length of stay in ICU after surgery(Up to 30 days after surgery)
- Incidence of Major Adverse Cardiovascular Events (MACEs) within 30 days after surgery(Up to 30 days after surgery)
- Incidence of other complications(Up to 30 days after surgery)
- 2 -year Major Adverse Cardiac and Cerebrovascular Events (MACCEs)-free survival after surgery(Up to 2 years after surgery)
- Cognitive function in 1- and 2-year survivors(At the end of the 1st and 2nd years after surgery)
- 2-year overall survival after surgery(Up to 2 years after surgery)
- Quality of life in 1- and 2- year survivors(At the end of the 1st and 2nd years after surgery)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine
Peking University First Hospital