Cognitive Assessment And Post-Operative Complications After Surgery: Linking Anaesthesia And Risk
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The proportion of eligible patients who consent to participate and are successfully screened for delayed neurocognitive recovery up to discharge or 7 days, whichever is sooner.
研究概览
简要总结
Many older people can experience confusion, memory problems, or a decline in their thinking after major surgery. These problems are sometimes called 'postoperative neurocognitive disorders' or PND and can affect recovery and a person's ability to live independently.
The investigators want to find out the best way to study these problems in older patients undergoing surgery. This is a 'feasibility study', which means we are testing the research methods. The investigators want to see if it is possible to ask participants to do memory tests and give blood samples before and after their operation. The investigators are hoping to include around 40 patients over 2 years in this study.
The investigators will compare performance in memory (cognitive assessment) findings before and after surgery and link this to data taken from the anaesthetic, including the types of drugs used, duration, brain features from processed electroencephalogram monitoring and standard recommended monitoring. In addition the investigators will link this to blood sample markers of brain health and function (biomarkers).
The results of this study will help the investigators plan a much larger study in the future, with the ultimate goal of making surgery safer for the brain.
详细描述
SUMMARY
Older patients can experience significant difficulties with memory and thinking (known as cognitive problems) after major surgery. The specific reasons in this vulnerable group are not yet clearly understood.
CAPSULAR is a single-centre feasibility research project at the Western General Hospital, Edinburgh, that aims to find the best way to conduct detailed research into this problem.
Objectives:
Main Aim:
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Seen in the Perioperative medicine for Older People undergoing Surgery (POPS) clinic
- •Scheduled for colorectal or urological surgery with expected anaesthesia time over 60 minutes
排除标准
- •Regional anaesthesia only
- •Planned day surgery or expected hospital stay < 24 hours
- •Expected to remain sedated and ventilated for > 24 hours postoperatively
- •Participant does not wish to remain in the study if capacity is lost during the study
- •CO-ENROLMENT
- •As this is a non-intervention study, co-enrolment will be permitted in other studies that do not conflict with this protocol.
研究组 & 干预措施
Perioperative medicine for Older People undergoing Surgery (POPS) clinic patients
Age > 70, scheduled for colorectal or urological surgery with expected anaesthesia time over 60 minutes.
干预措施: Montreal Cognitive Assessment (Other)
Perioperative medicine for Older People undergoing Surgery (POPS) clinic patients
Age > 70, scheduled for colorectal or urological surgery with expected anaesthesia time over 60 minutes.
干预措施: biomarkers (Diagnostic Test)
结局指标
主要结局
The proportion of eligible patients who consent to participate and are successfully screened for delayed neurocognitive recovery up to discharge or 7 days, whichever is sooner.
时间窗: Participants will be involved within the study from time of consent (expected at their POPS clinic visit) until up to 7-days after surgery or to hospital discharge (whichever is sooner).
The overall aim is to test the feasibility of this research being conducted on a larger scale. The primary outcome assesses the proportion of eligible patients who consent and then undergo pre- and post-operative cognitive testing.
次要结局
- The proportion of consented patients from whom a complete set of blood samples (pre-anaesthesia, post-anaesthesia, and up to discharge or 7 days, whichever is sooner) is successfully collected and stored.(Participants will be involved within the study from time of consent (expected at their POPS clinic visit) until up to 7-days after surgery or to hospital discharge (whichever is sooner).)
- The proportion of consented patients for whom complete anaesthetic data, including depth of anaesthesia parameters, are successfully retrieved from electronic records.(The time-gap between clinic and surgery depends upon many factors, as does post-operative duration. Participants will be involved within the study from time of consent until up to 7-days after surgery or to hospital discharge (whichever is sooner).)
- The incidence and nature of PND identified through domain-specific cognitive testing.(Participants will be involved within the study from time of consent (expected at their POPS clinic visit) until up to 7-days after surgery or to hospital discharge (whichever is sooner).)
研究者
Kieran Nunn
Consultant Anaesthetist
NHS Lothian