Risk Factors for Postoperative Delirium in Elderly Patients Undergoing Major Non-Cardiac Surgery in Singapore

NCT04617210 | Unknown

• 1 other identifier: 2020/00117
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim is to establish the risk factors, in particular the modifiable risk factors, for the development of POD in elderly patients undergoing major non-cardiac surgery in a tertiary hospital in Singapore. The secondary aims are:

1. 1.To establish the incidence of POD in elderly patients in Singapore, including the proportions that develop hypoactive, hyperactive and mixed delirium, as well as dementia within a one-year follow-up period;
2. 2.To understand the timeline of the development and peak incidence of POD, from the post-anaesthesia care unit till 3 days postoperatively;
3. 3.To compare the utility and accuracy (sensitivity and specificity) of two simplified delirium detection tools, 3D CAM and NuDESC, against the gold standard DSM-5 criteria, in our population as a means for monitoring POD as standard of care in the future;
4. 4.To collect data for holistic evaluation of neurobehavioural and daily functioning status

Conditions

Postoperative Delirium

Keywords

Geriatrics

Outcome Measures

Primary Outcomes (1)

• Establish the risk factors for the 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

  Before surgery through to 1 year post surgery

Study Arms (1)

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.

Other: Neurocognitive tests and blood taking

Interventions

Neurocognitive tests and blood taking OTHER

Battery of neurocognitive tests and questionnaires: MoCA, PHQ-9, Falls History, FIFE, STOPBANG, Nutritional Survey, CANTAB, Insomnia Severity Index, Bristol Activities of Daily Living Scale, NuDESC, 3D-CAM. Blood taking.

Surgical Cohort

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• History of psychiatric disease
• Unable to provide informed consent for surgery
• Illiterate
• An active history of substance abuse
• Undergoing neurosurgical procedures
• Undergoing emergency surgeries
• Has a second surgery within 5 days of index surgery
• Non-resident of Singapore
• Severe hearing and/or speech impairment

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Health System

Singapore, 119074, Singapore

RECRUITING

Related Publications (4)

• 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.

  PMID: 25926315 BACKGROUND

• Yang 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.

  PMID: 23569671 BACKGROUND

• Aldecoa 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.

  PMID: 28187050 BACKGROUND

• Evered 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.

  PMID: 30336844 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Emergence Delirium

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Ne-Hooi Will Loh

  National University Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ne-Hooi Will Loh

CONTACT

6772 4200; will_ne_hooi_loh@nuhs.edu.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 5, 2020
• Study Start: November 18, 2020
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)