Autonomic Cardiovascular Control for Elderly Surgery Patients

Study Overview
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Brief Summary
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The purpose of this study is to study aspects of autonomic cardiovascular control and the level of stress hormones and inflammatory markers in saliva or serum, in elderly patients exposed to elective, major abdominal surgery, with or without postoperative delirium, to explore the hypothesis that delirium may be the result of aberrant stress responses.

Detailed Description
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Patients admitted for elective, major, abdominal surgery will be tested with a head-up tilting to 20 degrees for 15 minutes preoperatively and again on the second postoperative day. Haemodynamic variables will be registered by the device TaskForceMonitor which monitors heart rate (HR), electrocardiography (ECG), blood pressure and stroke volume continuously and non-invasively. Background variables (including demographics, comorbidity and simple cognitive tests) and daily variables (including delirium assessments) will be registered. Blood and saliva samples will be drawn preoperatively and postoperatively to measure levels of stress hormones and inflammatory markers.

Official Title
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Autonomic Cardiovascular Control for Elderly Surgery Patients

Conditions
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Delirium

Intervention / Treatment
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* Procedure: Abdominal surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital Exclusion Criteria: Absence of a valid informed consent or assent, or consent from a legal proxy Patients with atrial fibrillation or a pacemaker rhythm Polyneuropathy Current treatment with beta-blockers, calcium-blockers or cholinesterase inhibitors Competing research project

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Abdominal surgery<br>Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital | Procedure: Abdominal surgery<br>* Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in orthostatic cardiovascular responses | Change in orthostatic cardiovascular responses (head-up tilt test) pre- and postoperatively in patients with and without postoperative delirium will be evaluated based on measurements of heart rate, systolic blood pressure (BP), mean BP, diastolic BP, stroke index, total peripheral resistance index, end-diastolic volume index, and acceleration index. | Baseline and postoperatively at surgical ward (expected second postoperative day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Activities of Daily Living (ADL) Scale | Score from 0-20 points | Baseline | 
| Nottingham Extended Activity of Daily Living (NEADL) Scale | Score from 0-66 points. | Baseline | 
| Cumulative Illness Rating Scale | Total score from 0-56. | Baseline | 
| Dementia | Simple cognitive tests preformed preoperatively, including MMSE, Clock Drawing Test, Trail making A and B and Ten word memory test. Also IQCODE when reliable information is present. | Baseline | 
| Delirium | Daily assessing the patient using the Confusion Assessment Method (CAM), shortened version. | Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days. | 
| Cortisol | Looking for differences in levels of cortisol in saliva (morning samples) pre-and postoperatively in patients developing delirium compared to patients not developing delirium. | Baseline and second postoperative day | 
| Severity of delirium | Daily assessing the patient using MDAS (the memorial delirium assessment scale). Total score from 0-30. | Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days | 
| Gait speed | Measuring comfortable gait speed at length of 4 meters, best result of 2 tests. Result in meter per second. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal surgery, Delirium, Autonomic cardiovascular control, Tilt-test