Postoperative Neurocognitive Dysfunction: Is There Any Place for Emergency Agitation: A Prospective Cohort Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- frequency of postoperative delirium
研究概览
简要总结
Perioperative neurocognitive disorders (PND) have been studying by clinicians, particularly by anesthesiologists, pretty long, however the most inspiring advancements were achieved during the last few decades. The most recent classification of PND which includes cognitive decline diagnosed before operation (described as neurocognitive disorder); any form of acute event (postoperative delirium) and cognitive decline diagnosed up to 30 days after the procedure (delayed neurocognitive recovery) and up to 12 months (postoperative neurocognitive disorder) was proposed in 2017. However at will one can notice at least one uncertainty that pertinent to the definition of delirium, emergency delirium and not mentioned in the classification discussed agitation.
The objective of the study is to determine if there is a difference between emergence agitation and emergence delirium.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 45 to 74 years
- •Undergoing elective orthopedic surgery
- •Provide written informed consent to participate in the PoD trial
排除标准
- •Undergoing emergent/urgent surgery
- •Montreal Cognitive Assessment < 18 points
- •History of mental disorders according ICD-11
- •Treated with at least one psychotropic drug
- •Patients with neuromuscular disease
- •Inability to undergo preoperative assessment for any reason
- •Previously enrolled in PoD trial
结局指标
主要结局
frequency of postoperative delirium
时间窗: 5 postoperative day
Percent of postoperative delirium
frequency of postoperative cognitive dysfunction
时间窗: 7 postoperative day
Percent of postoperative cognitive dysfunction
次要结局
- frequency of emergence delirium(immediately upon emergence from anesthesia)
- Length of postoperative delirium(5 postoperative day)
- Length of hospitalization(1 year)
- MACCE(1 year)
- 1-year mortality(1 year)
- frequency of emergence agitation(immediately upon emergence from anesthesia)
- Length of stay in ICU(1 year)
- MACE(1 year)
- 30-day mortality(30 day)
研究者
Valery Likhvantsev, MD
Head of the Research Negovsky Reanimatology Research Institute
Negovsky Reanimatology Research Institute