Elective Non-Cardiac Surgery, Postoperative Delirium
Conditions
Keywords
delirium, blood biomakers, endothelial dysfunction, blood brain barrier (BBB)
Brief summary
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 .
Detailed description
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 .
Interventions
DIAGNOSTIC_TESTNeuropsychological tests
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.
Sponsors
Xuzhou Medical University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing selective major noncardiac surgery and general anesthesia; 2. Age 60-90 yrs; 3. Anesthesia Society of American (ASA) Scale II\ III; 4. Anticipated surgery time 2-6 hrs 5. Written informed consent;
Exclusion criteria
1. decline to participate 2. Dementia patients（Mini-mental state examination\< 20） 3. Factors existed that affect cognition assessment such as language,visual,and auditory dysfunction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of postoperative delirium | From day 0 to up to 3 days after the surgery | 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. |
| serum concentration change in biomarker of endothelial dysfunction | baseline, postoperative day 1 | C-terminal endothelin-1 (CT-proET-1) to be measured at 2 time points |
| serum concentration change in biomarker of blood brain barrier disruption | baseline, postoperative day 1 | caveolin-1 to be measured at 2 time points |
| serum concentration change in biomarker of neuronal injury | baseline, postoperative day 1 | Neurofilament light (NfL) to be measured at 2 time points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery Score - 40 (QoR-40) at baseline | 1 day before the surgery(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). |
| Quality of Recovery Score - 40 (QoR-40) after surgry | 1 day after the surgery | 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). |
| The severity of pain at baseline | 1 day before the surgery(baseline) | Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain. |
| The severity of pain after surgry | From day 0 to up to 3 days after the surgery | Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain. |
Countries
China
Contacts
Primary ContactJunli Cao
Backup ContactYuan Han
Outcome results
None listed