Postoperative DeliriumNCT04792554
Singapore Perioperative Ageing Study (Sing-PAS)
An observational study of Postoperative Delirium and Aging, run by National University Hospital, Singapore at 2 sites in Singapore.
Trial summary
The specific aim of the study will be to set up a perioperative database to longitudinally track the progress of elderly patients undergoing major surgery from the preoperative period to five years postoperatively. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Postoperative Delirium, Aging, Myocardial Injury
- What is being tested?
- Neurocognitive tests and blood taking
- How many people
- 600 participants
- Where
- 2 sitesSingapore
- Study dates
- 7 Apr 2021to Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients aged 65 and above who are planned for major non-cardiac surgery predicted to be at least 2 hours in duration and requiring at least 1 postoperative stay in hospital.
Who may be able to join
- Elderly patients aged 65 years and above
- Undergoing major non-cardiac surgery, defined as surgery that is predicted to be at least 2 hours and requiring at least 1 day postoperative stay in the hospital
- English, Chinese or Malay speaking
- Ability to provide informed consent
Who cannot join
- History of psychiatric disease
- Illiterate
- An active history of substance abuse.
- Undergoing neurological procedures
- Undergoing emergency surgeries
- Has a second surgery planned within 5 days of index surgery
- Non-resident of Singapore
- Severe hearing and/or speech impairment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lian Kah Ti contact
Singapore2 sites, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Lian Kah Ti, 67724200, lian_kah_ti@nuhs.edu.sg
Lian Kah Ti
- Active, not recruiting
Alexandra Hospital
Singapore, 159964
About this study
The specific aim of the study will be to set up a perioperative database to longitudinally track the progress of elderly patients undergoing major surgery from the preoperative period to five years postoperatively. This database will form the foundation of a programme that will be sustainable through future grants to implement clinical strategies to improve outcomes.
Read the detailed description
Singaporeans are rapidly ageing. One in every 4 Singaporeans will be aged 65 years and older in 2030, double the rate of that in 2015. Elderly patients have more chronic diseases and have a poorer recovery profile after illness or surgery. More recently, it has been reported that Singaporeans spend 10 years of their lives in poor health. Elderly patients are over-represented in patients coming for surgery, particularly for major cardiac and non-cardiac surgeries. While surgery is wonderful and lifesaving, the truth is that many elderly patients do not do well after major surgery. This was eloquently reported in the New York Times recently in an article titled "The Elderly Are Getting Complex Surgeries. Often It Doesn't End Well." Elderly patients value quality of life over quantity of life, but many are not aware of the long-term debilitation, organ dysfunction, pain, depression, economic burden and social strain that frequently accompanies major surgery. Elderly patients are more likely to lose independence after surgery, both physically and cognitively, and may never recover fully. There is clearly a disconnect between the elderly patient's (and their loved ones') expectations and reality. There is therefore a need to look closely at the operative journey of the elderly patient undergoing major surgery. Currently, clinical care is primarily concerned about achieving a technically successful surgery and recovery in the immediate postoperative phase, but there is much less oversight once the patient leaves the hospital system to community care. However, perioperative management significantly impacts the quality of life and activities of daily living for years after surgery. At NUHS, the MILES (Management and Innovation for Longevity in Elderly Surgical patients) programme has successfully reduced hospital length of stay of elderly patients undergoing abdominal surgery by addressing frailty and performing prehabilitation in selected patients. In this study, the study team intend to expand on this clinical programme to look at 3 primary concerns, namely postoperative delirium, trajectory of ageing, and myocardial injury, and the long-term implications of these concerns. Second, the team will incorporate biomarkers and other investigations to better risk profile patients, elucidate mechanistic processes, and provide better diagnostic and prognostic tools to clinicians. Third, the team will investigate the complimentary and detrimental roles of common systemic pathologies such as diabetes, anemia, renal dysfunction, malignancy, pain, and poor sleep on these outcomes. Therefore, the team intends to do a longitudinal study starting from the preoperative period up to 5 years after surgery in patients aged 65 years and above undergoing elective non-cardiac major surgery, defined as a surgery lasting at least 2 hours and requiring at least one day stay in hospital after surgery. It is envisioned that by using the data gained from this study, the investigators will be able to identify risk factors, trajectories of outcomes and gaps in their clinical care, and from there, formulate clinical strategies to address these gaps and mitigate the risk factors.
- Conditions
- Postoperative Delirium, Aging, Myocardial Injury
- Being tested
- Neurocognitive tests and blood taking
- Keywords
- Geriatrics
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive tests and blood takingOther
Battery of neurocognitive tests and questionnaires including MoCA, PHQ-9, Falls History, FIFE, STOPBANG, Nutritional Survey, Global Physical Activity Questionnaire, Brief Pain Index, Brief Psychiatric Rating Scale, NuDESC, 3D-CAM. Blood taking.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Cohort | Elderly patients aged 65 and above who are planned for major non-cardiac surgery predicted to be at least 2 hours in duration and requiring at least 1 postoperative stay in hospital. Receives: Other: Neurocognitive tests and blood taking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of POD in elderly patients undergoing major non-cardiac surgery in a tertiary hospital in Singapore
Collection of patient's demographics, medical records and surgical records to establish risk factors for POD development
Measured: Before surgery through to 5 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start7 Apr 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Lian Kah Ti, Principal investigator, National University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792554
- Sponsor's protocol ID
- 2020/00152
- Status last verified
- Sep 2022
- First submitted
- 8 Mar 2021
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rose J, Weiser TG, Hider P, Wilson L, Gruen RL, Bickler SW. Estimated need for surgery worldwide based on prevalence of diseases: a modelling strategy for the WHO Global Health Estimate. Lancet Glob Health. 2015 Apr 27;3 Suppl 2(Suppl 2):S13-20. doi: 10.1016/S2214-109X(15)70087-2.
PubMed 25926315Yang R, Wolfson M, Lewis MC. Unique Aspects of the Elderly Surgical Population: An Anesthesiologist's Perspective. Geriatr Orthop Surg Rehabil. 2011 Mar;2(2):56-64. doi: 10.1177/2151458510394606.
PubMed 23569671Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594.
PubMed 28187050Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 15.
PubMed 30336844