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

NCT04330950 | Completed

• 1 other identifier: 2019/00703
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Postoperative Delirium

Keywords

Geriatrics; Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Postoperative through study completion, an average of 1 year

Study Arms (1)

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

Other: Neurocognitive tests

Interventions

Neurocognitive tests OTHER

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

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 of at least 2 hours in duration and requiring at least 1 postoperative stay in hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (4)

Khoo Teck Puat Hospital

Singapore, Singapore

Location

National University Hospital

Singapore, Singapore

Location

Singapore General Hospital

Singapore, Singapore

Location

Tan Tock Seng Hospital

Singapore, Singapore

Location

Related Publications (6)

• 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

• Inouye 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.

  PMID: 23992774 BACKGROUND

• American 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.

  PMID: 25535170 BACKGROUND

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

• Lian Kah Ti

  National University Health System

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 2, 2020
• Study Start: March 10, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (4)