Autonomic Cardiovascular Control for Elderly Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in orthostatic cardiovascular responses
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital
排除标准
- •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
结局指标
主要结局
Change in orthostatic cardiovascular responses
时间窗: Baseline and postoperatively at surgical ward (expected second postoperative day)
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.
次要结局
- Cortisol(Baseline and second postoperative day)
- Severity of delirium(Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days)
- Delirium(Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days.)
- Gait speed(Baseline)
- Barthel Activities of Daily Living (ADL) Scale(Baseline)
- Nottingham Extended Activity of Daily Living (NEADL) Scale(Baseline)
- Cumulative Illness Rating Scale(Baseline)
- Dementia(Baseline)