Postoperative DeliriumNCT04330950
Postoperative Delirium in Elderly Patients Undergoing Major Non-Cardiac Surgery in Singapore
An observational study of Postoperative Delirium, run by National University Hospital, Singapore at 4 sites in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Neurocognitive tests
- How many people
- 98 participants
- Where
- 4 sitesSingapore
- Study dates
- 10 Mar 2020to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 of 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 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
Who cannot join
- Undergoing emergency surgery
- Undergoing surgery under local anaesthesia
- History of psychiatric disease
- Illiterate
- Active history of substance abuse
- Undergoing neurosurgical procedures
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Singapore4 sites
Khoo Teck Puat Hospital
Singapore
National University Hospital
Singapore
Singapore General Hospital
Singapore
Tan Tock Seng Hospital
Singapore
About this study
Official title: A Preliminary Study of the Incidence, Risk Factors and Sequelae of Postoperative Delirium in Elderly Patients Undergoing Major Non-Cardiac Surgery in Singapore
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.
Read the detailed description
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.
The current accepted standard for diagnosing POD is to perform twice daily neurocognitive assessments daily in the first 5 postoperative days. However, as this is difficult to implement due to the significant manpower requirements, delirium in the post-anaesthesia care unit (PACU delirium) has been used as a surrogate for POD. PACU delirium is distinct from emergence delirium which occurs upon arrival or soon after admission into the PACU and is related to residual effects of anaesthesia. Emergence delirium typically is self-limiting and has no long-term sequelae. In contrast, PACU delirium occurs after recovery from the effects of anaesthesia, presenting at 30-60 minutes after arrival in the PACU. PACU delirium occurs in up to 80% of patients who subsequently develop POD in the wards and has been independently associated with increased length of hospitalization, unplanned readmission, and increased in-hospital mortality.
Therefore, 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. This study will provide preliminary data to enable the investigators to apply for a national grant for a more definitive and adequately powered study. It is envisaged that eventually, the information gathered will allow the investigators to form an effective clinical plan to reduce postoperative delirium in our elderly patients undergoing non-cardiac surgery, and a basis to apply for national grant funding to implement the clinical intervention.
- Conditions
- Postoperative Delirium
- Being tested
- Neurocognitive tests
- Keywords
- Geriatrics, Postoperative Delirium
- 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 testsOther
Preoperative: Battery of neurocognitive tests and questionnaires (MoCA, PHQ-9, Falls History, FIFE, STOPBANG, Nutritional Survey) Postoperative in PACU: NuDESC test Postoperative 30 days: 10 minute phone interview
| Study group | Role | What they receive |
|---|---|---|
| Surgical Cohort | Preoperative: Battery of neurocognitive tests and questionnaires (MoCA, PHQ-9, Falls History, FIFE, STOPBANG, Nutritional Survey) Postoperative in PACU: NuDESC test Postoperative 30 days: 10 minute phone interview Receives: Other: Neurocognitive tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the incidence, risk factors and sequelae of postoperative delirium in elderly patients undergoing major non-cardiac surgery in Singapore
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
Measured: After surgery through to postoperative day 30
Secondary outcomes (1)
Look for EEG markers of POD that may potentially lead to the development of a POD monitor
Look for EEG markers of POD that may potentially lead to the development of a POD monitor
Measured: Postoperative through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start10 Mar 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lian Kah Ti, Principal investigator, National University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330950
- Sponsor's protocol ID
- 2019/00703
- Other IDs
- 2019
- Status last verified
- Sep 2022
- First submitted
- 27 Mar 2020
- 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 30336844Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
PubMed 23992774American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14. No abstract available.
PubMed 25535170
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study of the Incidence, Risk Factors and Sequelae of Postoperative Delirium in Elderly Patients Undergoing Major Non-Cardiac Surgery in Singapore
- ClinicalTrials.gov ID
- NCT04330950
- Acronym / sponsor ID
- 2019/00703
- Conditions
- Postoperative Delirium
- Keywords
- Geriatrics, Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The current accepted standard for diagnosing POD is to perform twice daily neurocognitive assessments daily in the first 5 postoperative days. However, as this is difficult to implement due to the significant manpower requirements, delirium in the post-anaesthesia care unit (PACU delirium) has been used as a surrogate for POD. PACU delirium is distinct from emergence delirium which occurs upon arrival or soon after admission into the PACU and is related to residual effects of anaesthesia. Emergence delirium typically is self-limiting and has no long-term sequelae. In contrast, PACU delirium occurs after recovery from the effects of anaesthesia, presenting at 30-60 minutes after arrival in the PACU. PACU delirium occurs in up to 80% of patients who subsequently develop POD in the wards and has been independently associated with increased length of hospitalization, unplanned readmission, and increased in-hospital mortality.
Therefore, 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. This study will provide preliminary data to enable the investigators to apply for a national grant for a more definitive and adequately powered study. It is envisaged that eventually, the information gathered will allow the investigators to form an effective clinical plan to reduce postoperative delirium in our elderly patients undergoing non-cardiac surgery, and a basis to apply for national grant funding to implement the clinical intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Cohort | – | Other: Neurocognitive testsPreoperative: Battery of neurocognitive tests and questionnaires (MoCA, PHQ-9, Falls History, FIFE, STOPBANG, Nutritional Survey) Postoperative in PACU: NuDESC test Postoperative 30 days: 10 minute phone interview |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients aged 65 and above who are planned for major non-cardiac surgery of at least 2 hours in duration and requiring at least 1 postoperative stay in hospital.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- Undergoing emergency surgery
- Undergoing surgery under local anaesthesia
- History of psychiatric disease
- Illiterate
- Active history of substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurocognitive testsPreoperative: Battery of neurocognitive tests and questionnaires (MoCA, PHQ-9, Falls History, FIFE, STOPBANG, Nutritional Survey) Postoperative in PACU: NuDESC test Postoperative 30 days: 10 minute phone interview | Other | Surgical Cohort |
Primary outcome
Investigate the incidence, risk factors and sequelae of postoperative delirium in elderly patients undergoing major non-cardiac surgery in Singapore
Time frame: 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
1 secondary outcome
Look for EEG markers of POD that may potentially lead to the development of a POD monitor
Time frame: Postoperative through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Background: PubMed 25926315Rose 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.
- Background: PubMed 23569671Yang 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.
- Background: PubMed 28187050Aldecoa 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.
- Background: PubMed 30336844Evered 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.
- Background: PubMed 23992774Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
- Background: PubMed 25535170American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lian Kah Ti principal investigator
National University Health System
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by National University Hospital, Singapore at 4 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate the incidence, risk factors and sequelae of postoperative delirium in elderly patients undergoing major non-cardiac surgery in Singapore (time frame: After surgery through to postoperative day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04330950, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.