Cognitive Assessment And Post-Operative Complications After Surgery: Linking Anaesthesia And Risk

NCT07470216 | Not Yet Recruiting

• 1 other identifier: AC25200
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Many older people can experience confusion, memory problems, or a decline in their thinking after major surgery. These problems are sometimes called 'postoperative neurocognitive disorders' or PND and can affect recovery and a person's ability to live independently. The investigators want to find out the best way to study these problems in older patients undergoing surgery. This is a 'feasibility study', which means we are testing the research methods. The investigators want to see if it is possible to ask participants to do memory tests and give blood samples before and after their operation. The investigators are hoping to include around 40 patients over 2 years in this study. The investigators will compare performance in memory (cognitive assessment) findings before and after surgery and link this to data taken from the anaesthetic, including the types of drugs used, duration, brain features from processed electroencephalogram monitoring and standard recommended monitoring. In addition the investigators will link this to blood sample markers of brain health and function (biomarkers). The results of this study will help the investigators plan a much larger study in the future, with the ultimate goal of making surgery safer for the brain.

Conditions

Cognitive Impairment; Cognitive Impairment, Mild; Anesthesia; Anesthesia Brain Monitoring; Cognitive Impairment, Progressive; Anesthesia Depth Monitoring

Keywords

cognitive impairment; cognitive impairment, mild; cognitive impairment, progressive; anesthesia; anesthesia brain monitoring; anesthesia depth monitoring

Outcome Measures

Primary Outcomes (1)

• The proportion of eligible patients who consent to participate and are successfully screened for delayed neurocognitive recovery up to discharge or 7 days, whichever is sooner.

  The overall aim is to test the feasibility of this research being conducted on a larger scale. The primary outcome assesses the proportion of eligible patients who consent and then undergo pre- and post-operative cognitive testing.

  Participants will be involved within the study from time of consent (expected at their POPS clinic visit) until up to 7-days after surgery or to hospital discharge (whichever is sooner).

Secondary Outcomes (3)

• The proportion of consented patients from whom a complete set of blood samples (pre-anaesthesia, post-anaesthesia, and up to discharge or 7 days, whichever is sooner) is successfully collected and stored.

  Participants will be involved within the study from time of consent (expected at their POPS clinic visit) until up to 7-days after surgery or to hospital discharge (whichever is sooner).

• The proportion of consented patients for whom complete anaesthetic data, including depth of anaesthesia parameters, are successfully retrieved from electronic records.

  The time-gap between clinic and surgery depends upon many factors, as does post-operative duration. Participants will be involved within the study from time of consent until up to 7-days after surgery or to hospital discharge (whichever is sooner).

• The incidence and nature of PND identified through domain-specific cognitive testing.

  Participants will be involved within the study from time of consent (expected at their POPS clinic visit) until up to 7-days after surgery or to hospital discharge (whichever is sooner).

Other Outcomes (1)

• New functional dependence at hospital discharge as identified by change in home social support or requirement for aids (e.g. Dossette box).

  Participants will be involved within the study from time of consent (expected at their POPS clinic visit) until up to 7-days after surgery or to hospital discharge (whichever is sooner).

Study Arms (1)

Perioperative medicine for Older People undergoing Surgery (POPS) clinic patients

Age \> 70, scheduled for colorectal or urological surgery with expected anaesthesia time over 60 minutes.

Other: Montreal Cognitive Assessment; Diagnostic Test: biomarkers

Interventions

Montreal Cognitive Assessment OTHER

Preoperative and Postoperative MoCA

Perioperative medicine for Older People undergoing Surgery (POPS) clinic patients

biomarkers DIAGNOSTIC_TEST

* Pre-operatively: sample collected at a suitable time of blood draw for routine peri-operative clinical samples or insertion of a peripheral venous cannula as part of routine anaesthetic care after consent and enrollment. This may be in the POPS clinic or on day of admission for surgery or when canulated for anaesthesia. * Immediate post-operative period: sample collected in recovery or on the ward at the first ordered routine blood-draw. * Up to 7 days post-surgery: sample collected on the ward (or last anticipated routine sample). Biomarkers assessed will be a panel linked to brain injury, inflammation, and cognitive impairment in non-ICU populations.

Perioperative medicine for Older People undergoing Surgery (POPS) clinic patients

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We will conduct a prospective, single-centre feasibility cohort study over a period of 24 months, recruiting patients from the Perioperative medicine for Older People having Surgery clinic (POPS) clinic at the Western General Hospital, Edinburgh, who are scheduled for major surgery. This is a pre-surgery clinic and physician-led inpatient follow up service with discharge planning roles. Note, the nature of the clinical pathway means that patients may wait several months from POPS clinic review until surgery.

You may qualify if:

• Age ≥ 70
• Seen in the Perioperative medicine for Older People undergoing Surgery (POPS) clinic
• Scheduled for colorectal or urological surgery with expected anaesthesia time over 60 minutes

You may not qualify if:

• Regional anaesthesia only
• Planned day surgery or expected hospital stay \< 24 hours
• Expected to remain sedated and ventilated for \> 24 hours postoperatively
• Participant does not wish to remain in the study if capacity is lost during the study
• CO-ENROLMENT
• As this is a non-intervention study, co-enrolment will be permitted in other studies that do not conflict with this protocol.

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Western General Hospital

Edinburgh, Midlothian, EH4 2XU, United Kingdom

Location

Related Publications (4)

• 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

• Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.

  PMID: 18156878 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

• Subramaniyan S, Terrando N. Neuroinflammation and Perioperative Neurocognitive Disorders. Anesth Analg. 2019 Apr;128(4):781-788. doi: 10.1213/ANE.0000000000004053.

  PMID: 30883423 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Mental Status and Dementia Tests; Environmental Biomarkers

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Biomarkers; Biological Factors; Biological Phenomena; Environmental Monitoring; Environmental Exposure; Environmental Pollution; Public Health; Environment and Public Health

Central Study Contacts

Kieran P Nunn, MB BS, BSc(h), FRCA, FFICM

CONTACT

+441315371652; kieran.nunn@nhs.scot

Zoeb Jiwaji, MBBCh, PhD, MRCP, FRCA, FFICM

CONTACT

+441315371652; zoeb.jiwaji@ed.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)