Effects of Limb Remote Ischemic Preconditioning for Prevention of Delirium in Elderly Patients After Non-cardiac Surgery:a Randomised, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 611
- 主要终点
- the incidence of delirium
研究概览
简要总结
To investigate whether limb remote ischemic preconditioning (LRIP) could safely decrease the incidence of delirium in elderly patients after non-cardiac surgery.
详细描述
Remote ischaemic preconditioning may confer the cytoprotection in critical organs. We hypothesized that limb remote ischemic preconditioning (RIPC) would safely decrease the incidence of delirium in elderly patients after non-cardiac surgery.The primary outcomes included the incidence of delirium in the first 7 days after surgery using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.The quality of recovery over a 6-month period was evaluated as well.Secondary endpoints included length of stay in the hospital after surgery (from day of surgery to hospital discharge), occurrence of non-delirium postoperative complications, and all-cause 6-month mortality.
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
- Triple (Care Provider, Investigator, 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
- •elderly patients received elective non-cardiac surgery with general anesthesia
- •anticipated surgery time > 2 hours
排除标准
- •age < 65 years old
- •Acute coronary syndrome or myocardial infraction within 3 months
- •Chronic obstructive pulmonary emphysema
- •Serious hepatic dysfunction (Child-Pugh class C)
- •serious renal dysfunction (undergoing dialysis before surgery)
- •Ejection fraction less than 40%
- •Poor pulmonary function (PaO2 <60mmHg)
- •Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis
- •Inability to communicate in the preoperative period (coma, profound dementia, or language barrier)
- •Brain injury or neurosurgery
研究组 & 干预措施
Limb RIPC
The limb RIPC protocol was applied after anesthetic induction and before the start of surgery. The limb RIPC was induced by placing a blood pressure cuff on the left upper arm of patient for three inflating-deflating cycles: 5 min inflating to 200 mmHg followed by a 5 min reperfusion with deflating the cuff.
干预措施: limb remote ischemic preconditioning(LRIP) (Procedure)
Convention
Elderly patients undergoing non-cardiac surgery received no treatment after induction of anaesthesia
结局指标
主要结局
the incidence of delirium
时间窗: in the first 7 days after surgery
次要结局
未报告次要终点
研究者
Kexuan Liu
Department of Anesthesiology, Nanfang Hospital, Southern Medical University, Guangzhou, China
Nanfang Hospital, Southern Medical University