NCT04505059Unknown不适用
Effect of Different Anesthetic Strategies on Postoperative Cognitive Function and Delirium in Adult Patients Undergoing Cardiac Surgery
China National Center for Cardiovascular Diseases4 个研究点 分布在 1 个国家目标入组 502 人开始时间: 2020年9月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 502
- 试验地点
- 4
- 主要终点
- Rate of postoperative delirium
研究概览
简要总结
This is a prospective, multi-center, double-blind, randomized clinical trials.
详细描述
Prospective randomized multi-center trial involving about 502 subjects will be enrolled in 3 centers. Patients will be randomized to two groups in equal proportion. Investigators set a hypothesis that precision cardiac anesthesia, which involves the modification of several crucial anesthetic modalities, would reduces the incidence of postoperative cognitive function and delirium in patients undergoing 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged≥18 years;
- •ASA:I to III;
- •Hemodynamic stability, LVEF≥40%;
- •Cardiac surgery including CABG, valve surgery, CABG combined with valve surgery, surgical repair of ASD,VSD and atrial myxoma, and other types.
排除标准
- •Declined to get involved;
- •Emergency cases, heart transplantation;
- •Severe hepatic insufficiency (Child-Pugh grades C),Severe renal insufficiency (requirement of renal replacement therapy);
- •Previous history of drug and alcohol abuse,allergy to general anesthetics;
- •Preoperative severe dementia, language barrier and mental illness
- •Preoperative schizophrenia, epilepsy, stroke and Parkinson's disease
- •Previous history of craniocerebral injury or neurosurgery;
- •Any other conditions that are considered unsuitable for study participation.
结局指标
主要结局
Rate of postoperative delirium
时间窗: Postoperative day 1 to 5
Delirium assessed by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period
次要结局
- Length of stay(up to 2 months after surgery)
- S-100β protein(Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery)
- Postoperative pain(Postoperative day 1 to 5, at 1,6 and 12 months after surgery)
- IGF-1(Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery)
- Cost(up to 2 months after surgery)
- Postoperative cognitive function(In hospital,up to 10 days, at 1,6 and 12 months after surgery)
- TNF-α(Before surgery, 6h, postoperative day 1(POD1 )morning, 24h after surgery)
- CRP(Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery)
- Genotype(Before surgery)
- Ventilation time(up to 1 month after surgery)
- PONV(Postoperative day 1 to 5)
- IL-6, IL-8, IL-10(Before surgery, 6h, postoperative day 1 (POD1) morning, 24h,after surgery)
研究者
Yuefu Wang
Professor
China National Center for Cardiovascular Diseases
研究点 (4)
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