NCT01881646已完成4 期
Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery
Karolinska University Hospital0 个研究点目标入组 8 人开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 主要终点
- Binding of the PET probe [11C]PBR28
研究概览
简要总结
The main purpose of this study is to assess the induction of neuroinflammation in brain regions of interest for learning and memory in adult patients undergoing urological surgery under general anesthesia
详细描述
The investigators aim to study immune cell activation as a biomarker for neuroinflammation using the cell specific [11C]PBR28 probe as detected by PET imaging techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 60-75 years of age. American Society for Anesthesiologist' criteria (ASA) physical status I-III
- •Lower abdominal surgery (hysterectomy/prostatectomy) under general anaesthesia
- •Obtained consent within 3 months before execution of the study.
排除标准
- •Patient's refusal to participate in the trial
- •Ongoing smoking, snuff or other nicotine compound treatment
- •Disabling neuropsychiatrical disorder (a Mini mental State Examination (MMSE) score ≤ 24, diagnosis of dementia, Mb Alzheimer, Mb Parkinson, schizophrenia, or mental depression) or other signs of significant cognitive decline.
- •History of stroke with neurological sequelae
- •Surgical procedure scheduled for regional anaesthesia.
- •Severe cardia and/or renal and/or hepatic impairment.
- •Coagulopathy.
- •Terminal phase of a chronic disease.
- •Patient on steroidal or non-steroidal anti-inflammatory drugs.
- •Admission B-Glucose > 15 mmol/litre or poorly controlled diabetes mellitus.
- •Presumed uncooperativeness or legal incapacity.
- •Preoperative or later postoperative B-hemoglobin < 90 g/L.
结局指标
主要结局
Binding of the PET probe [11C]PBR28
时间窗: Preoperatively, once at postoperative day 2-5 and after 3 month
PET imaging of brain regions of relevance for memory and learning will be compared between the pre- and postoperative states.
次要结局
- Cognitive testing(Preoperatively and after 3 month)
- Inflammatory biomarkers(Preoperatively, once at postoperative day 2-5 and after 3 month, i.e. at the same time as the PET investigation)
研究者
Lars I Eriksson
Professor
Karolinska University Hospital
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