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临床试验/NCT04330950
NCT04330950已完成不适用

A Preliminary Study of the Incidence, Risk Factors and Sequelae of Postoperative Delirium in Elderly Patients Undergoing Major Non-Cardiac Surgery in Singapore

National University Hospital, Singapore4 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2020年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
4
主要终点
Investigate the incidence, risk factors and sequelae of postoperative delirium in elderly patients undergoing major non-cardiac surgery in Singapore

研究概览

简要总结

The primary aim of this study is to investigate the incidence, risk factors and sequelae of postoperative delirium in elderly patients undergoing major non-cardiac surgery in Singapore. The secondary aim of this study is to look for EEG markers of POD that may potentially lead to the development of a POD monitor.

详细描述

Singapore's population is growing older and increasingly burdened with systemic disease. It is estimated that over 320 million people underwent surgery worldwide in 2010, with Asia being the fastest growing region. Elderly patients aged >65 years are presenting for surgery at an ever-increasing rate. In the United States, studies have estimated that approximately 53% of all surgical procedures are performed on patients over the age of 65. Projections estimate that approximately half of the population over the age of 65 will require surgery once in their lives.

It is recognized that for elderly patients, quality of life after surgery matter more than quantity of life. Elderly patients have diminished reserves and poorer recovery potential. Therefore, to fully benefit from surgery, it is essential to adopt measures to preserve quality of life in addition to survival after surgery in the perioperative period. One example is the enhanced recovery after surgery (ERAS) programme where protocolized care involving optimal analgesia, less invasive surgeries, early mobilisation and early hospital discharge has improved the recovery of patients after surgery. In the best practice guidelines for care of elderly surgical patients put forward by the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) and the American Geriatrics Society (AGS) published in 2012, anaesthesia plays a role in more than half of the 13 recommendations put forward.

One of these recommendations is to reduce postoperative delirium (POD). The anaesthetic agents we use is toxic to the brain, and deep anaesthesia causes POD, which is linked to increased hospital length of stay, unplanned hospital readmissions, increased 30-day mortality, and dementia. POD is one of the leading causes of why patients fall at home after surgery. Up to 10% will develop long-term neurocognitive deficits, which in turn diminish the quality of life and levy a tremendous socio-economic burden on family and care-givers, and shortens life. The topic of POD has dominated the anaesthesia literature in the last year, with both the US and European societies issuing best practice guidelines such as the Brain Health Initiative and the Safe Brain Initiative, as well as harmonization of the definitions of postoperative neurological outcomes with that used by neurologists in compliance with DSM-5 definitions to allow for collaborative solutions.

More recently it was reported in the Straits Times that Singaporeans have the longest life expectancy in the world. However, 10.7 years of this is spent in poor health, with diminished mental health ranking as the second most important cause for this. Because POD is strongly linked to the development of dementia and/or alters the trajectory at which age-related dementia occurs, it is very important to prevent the development of POD. This is particularly so as studies have shown that POD is very common, occurring in as many as 11-50% of patients undergoing major non-cardiac surgery, and that up to 40% of POD is preventable.

Awareness of POD remains poor amongst both doctors and the public. The reason for this is that POD requires specialized neurological testing and currently, there are no established biomarkers or monitors to detect it. Anecdotally, POD is one of the leading reasons for in-hospital (blue letter) psychiatric referrals after surgery in NUHS, as delirious patients will refuse to comply with physiotherapy, medications and wound care, leading to delayed healing, infection and delayed discharge. Patients are not routinely assessed for POD and can be discharged from hospital with it. Patients who are still delirious can end up with poor feeding and self-care, and even hurt themselves leading to rehospitalisation. In short, POD is a common yet under-diagnosed, and potentially preventable, complication of anaesthesia and surgery in the elderly that has significant long-term effects on the independence of patients after surgery and their quality of life.

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
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elderly patients aged 65 and above
  • Undergoing major non-cardiac surgery, defined as a surgery that is at least 2 hours in duration and requiring at least 1 day postoperative stay in hospital

排除标准

  • Undergoing emergency surgery
  • Undergoing surgery under local anaesthesia
  • History of psychiatric disease
  • Illiterate
  • Active history of substance abuse
  • Undergoing neurosurgical procedures
  • A second surgery planned within 5 days of index surgery
  • Non-resident of Singapore
  • Deaf, dumb or mute
  • Patients planned for admission into the Intensive Care Unit after surgery
  • Pregnant women

结局指标

主要结局

Investigate the incidence, risk factors and sequelae of postoperative delirium in elderly patients undergoing major non-cardiac surgery in Singapore

时间窗: After surgery through to postoperative day 30

By collecting the patient's demographics, medical records and surgical records, and looking at their outcome, we aim to investigate the incidence and risk factors of postoperative delirium in this elderly cohort in Singapore

次要结局

  • Look for EEG markers of POD that may potentially lead to the development of a POD monitor(Postoperative through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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