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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70+
SponsorUniversity of Edinburgh

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Montreal Cognitive Assessment

    Other intervention

    Preoperative and Postoperative MoCA

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Perioperative medicine for Older People undergoing Surgery (POPS) clinic patients2 interventions

Trial outcomes

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.

Time frame
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

1

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.

The overall aim is to test the feasibility of this research being conducted on a larger scale. The outcome assesses the proportion of eligible patients who consent and then provide pre-, immediately-post-operative and pre-discharge biomarker blood samples (additional tubes/samples from routine blood-lets).

Time frame
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).
2

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

The overall aim is to test the feasibility of this research being conducted on a larger scale. The outcome assesses the proportion of eligible patients who consent and then have a complete intraoperative data-set collected.

Time frame
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).
3

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

Analysis of the performance in the Montreal Cognitive Assessment (MoCA) tool allows us to both analyse incidence, but also features of, any identified cognitive changes across the timespan of the patients preparation and undertaking of surgery.

Time frame
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).

New support for independent living or new dependence will be recorded at the point the patient leaves the study in order to better understand this and plan for the economic impact analysis in a future study.

Time frame
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).

Sponsors and contacts

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