Correlation Between Blood Biomarkers and Postoperative Delirium in Elective Non-Cardiac Surgery.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-04-30

Brief Summary

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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 .

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Detailed Description

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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 .

Conditions

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Postoperative Delirium Elective Non-Cardiac Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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POD group

POD group refers to the patients who were diagnosed to be delirious by the Confusion Assessment Method.

Neuropsychological tests

Intervention Type 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.

Non-POD group

Non-POD refered to the patients who did not become delirious by the Confusion Assessment Method.

Neuropsychological tests

Intervention Type 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.

Interventions

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Neuropsychological 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No