Delirium Reduction by Volatile Anesthesia in Cardiac Surgery: Prospective, Randomized, Single-blinded Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 405
- 试验地点
- 5
- 主要终点
- Postoperative delirium
研究概览
简要总结
Parallel group, prospective, randomized, controlled, single-blinded trial. The aim of our study is to test the hypothesis that volatile anesthesia would reduce the incidence of early postoperative delirium in patients undergoing cardiac surgery with CPB as compared to TIVA.
详细描述
Delirium is a common neurologic complication after cardiac surgery. Up to 52% of postoperative cardiac surgery patients have delirium. The occurrence of postoperative delirium is associated with worse outcomes, including prolonged length of stay in the ICU and hospital, increased morbidity and mortality, compromised long-term cognitive function and physical ability, and elevated medical care costs. Morbidity of postoperative cognitive dysfunction and delirium mostly common in patients with age more than 60 years.
Several factors including cerebral anoxia, embolism, excessive excitatory neurotransmitter release, systemic inflammatory response, electrolyte and metabolic disorders and hemodynamic changes have been demonstrated to contribute to postoperative neurological dysfunction and delirium.
Previous studies have shown that inhalation anaesthesia and total intravenous anaesthesia (TIVA) may produce different degrees of cerebral protection in these patients. Effects of this two types of anaesthesia in cardiac surgery with CPB remain controversial and much debated.
Inhalation agents depress glucose metabolism, decrease cerebral metabolic rate and oxygen consumption. They also partially uncouple the reactivity of cerebral blood flow to CO2. The changes in cerebral blood flow (CBF) depend on the changes in cerebral metabolism and on direct vasodilatory effects. Cerebral autoregulation is dose-dependently altered. Volatile anaesthetics have been shown to initiate early ischemic preconditioning in neurons, but models of focal brain ischemia suggest it can take 24 h for preconditioning to develop fully.
Propofol is a well-known potentiator of GABAA receptors, it reduces cerebrovascular resistance, CBF and cerebral oxygen delivery during cardiopulmonary bypass. A neuroprotective effect of propofol has been shown to be present in many in vitro and in vivo established experimental models of mild/moderate acute cerebral ischemia.
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
- Single (Participant)
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
- •Males and females > 65 years
- •Written informed consent
- •Cardiac surgery with CPB
排除标准
- •Emergency surgery
- •Surgery on aorta
- •Known allergy to components of anaesthesia
- •Pregnancy
- •Hemodynamically significant stenosis of carotid arteries
- •Parkinson's disease
- •Liver cirrhosis (Child B or C)
- •Current enrollment into another RCT (in the last 30 days)
- •Previous enrollment and randomization into the DELICATE trial
- •Poor language comprehension
- •Preoperative Medications: Anticholinergics (dimedrol, atropine, dramina), antidepressants, antiepileptics, antiparkinson drugs, chemotherapeutic agents
研究组 & 干预措施
Volatile anesthesia group
干预措施: Volatile agent (Drug)
TIVA group
干预措施: Propofol (Drug)
结局指标
主要结局
Postoperative delirium
时间窗: 5 days after surgery
Postoperative delirium detection will be managed with Confusion Assessment Method for the ICU (CAM-ICU)
次要结局
- Myocardial infarction (MI)(30 days)
- One-year all-cause mortality(1 year)
- Early postoperative cognitive dysfunction(7 days after surgery)
- Delirium duration(10 days after surgery)
- Duration of ICU stay(30 days)
- Duration of hospital stay(60 days)
- 30-day all-cause mortality(30 days)
- Stroke(30 days)
- Seizures(30 days)
- Incidence of acute kidney injury (AKI)(30 days)
- Renal replacement therapy(30 days)
- Infectious complications(30 days)
- Pain assessment with Behavioral Pain Scale (BPS)(5 days after surgery)
- Pain assessment with Numerical Rating Scale (NRS)(5 days after surgery)