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More than 20% of patients over 60 years old develop postoperative delirium following non-cardiac surgery . Delirium increases morbidity and mortality , and may lead to long-term cognitive impairment . The underlying mechanisms behind delirium are not understood , endothelial dysfunction and disruption of the blood brain barrier (BBB ) caused by perioperative systemic inflammation may play a important role in the development of delirium . This study intends to evaluate the relationship between neuroinflammation and postoperative delirium in elderly non-cardiac surgery patients . The results of the study are to identify risk factors and explore the biomarkers most closely linked to each step of the proposed pathway .
The investigators do the neuropsychological tests , Mini-Mental score examination (MMSE ) , Charlson Comorbidity Index (CCI ) , Quality of Recovery Score - 40 (QoR-40 ) 1 day before the surgery(baseline ) . Serum of the patients was collected before operation and at POD1 , and then detect the concentration change of biomarkers of endothelial dysfunction , blood brain barrier disruption and neuronal injury . Also , the patients were interviewed once before discharge from PACU and twice on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups . Meanwhile , the severity of pain (Numerical Rating Scale(NRS )) was evaluated at the same time and QoR-40 at 1 day after surgery .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POD group | POD group refers to the patients who were diagnosed to be delirious by the Confusion Assessment Method. |
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| Non-POD group | Non-POD refered to the patients who did not become delirious by the Confusion Assessment Method. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuropsychological tests | Diagnostic Test | The investigators do the neuropsychological tests, Mini-Mental score examination (MMSE),Charlson Comorbidity Index(CCI),Quality of Recovery Score - 40 (QoR-40),CAGE Alcoholism Questionnaire,blood albumin、hemoglobin content、ALT、AST、BUN、Cr、1 day before the surgery(baseline);serum biomarkers of endothelial dysfunction,blood brain barrier disruption and neuronal injury to be measured at 2 time points,1 day before the surgery(baseline)and postoperative day 1; Confusion Assessment Method(CAM),Numerical Rating Scale(NRS)once before discharge from PACU and 1、2、3 days after surgery twice a day; QoR-40 1 day after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| serum concentration change in biomarker of endothelial dysfunction | C-terminal endothelin-1 (CT-proET-1) to be measured at 2 time points | baseline, postoperative day 1 |
| serum concentration change in biomarker of blood brain barrier disruption | caveolin-1 to be measured at 2 time points | baseline, postoperative day 1 |
| serum concentration change in biomarker of neuronal injury | Neurofilament light (NfL) to be measured at 2 time points | baseline, postoperative day 1 |
| The incidence of postoperative delirium | The patients were interviewed one day before the surgery and on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups. | From day 0 to up to 3 days after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery Score - 40 (QoR-40) at baseline | Quality of recovery will be evaluated by Quality of Recovery 40 (QoR40),which assesses five dimensions of recovery (physical comfort,emotional state, physical independence , physiological support and pain ). Each item is rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged ≥60 years undergoing elective non-cardiac major surgery under general anesthesia were investigated.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junli Cao | Contact | +86 15162160809 | caojl0310@yahoo.com.cn | |
| Yuan Han | Contact | +86 13852470693 | hanyuan_trial@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Junli Cao | Recruiting | Xuzhou | Jiangsu | 221000 | China |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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urine and blood
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| 1 day before the surgery(baseline) |
| Quality of Recovery Score - 40 (QoR-40) after surgry | Quality of recovery will be evaluated by Quality of Recovery 40 (QoR40),which assesses five dimensions of recovery (physical comfort,emotional state, physical independence , physiological support and pain ). Each item is rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery). | 1 day after the surgery |
| The severity of pain at baseline | Evaluate the severity using numerical rating scale(NRS), where zero mean no pain and 10 the worst imaginable pain. | 1 day before the surgery(baseline) |
| The severity of pain after surgry | Evaluate the severity using numerical rating scale(NRS), where zero mean no pain and 10 the worst imaginable pain. | From day 0 to up to 3 days after the surgery |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |