Clinical trial NCT03915314: Correlation Between Blood Biomarkers and Postoperative Delirium in Elective Non-Cardiac Surgery.
Official title: The Association Between Blood Biomarkers and Postoperative Delirium in Elective Non-Cardiac Surgery Under General Anesthsia.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Delirium
Elective Non-Cardiac Surgery
Keywords: delirium
blood biomakers
endothelial dysfunction
blood brain barrier (BBB)
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged ≥60 years undergoing elective non-cardiac major surgery under general anesthesia were investigated.

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: serum concentration change in biomarker of endothelial dysfunction
timeFrame: baseline, postoperative day 1
measure: serum concentration change in biomarker of blood brain barrier disruption
timeFrame: baseline, postoperative day 1
measure: serum concentration change in biomarker of neuronal injury
timeFrame: baseline, postoperative day 1
measure: The incidence of postoperative delirium
timeFrame: From day 0 to up to 3 days after the surgery
Secondary outcomes:
measure: Quality of Recovery Score - 40 (QoR-40) at baseline
timeFrame: 1 day before the surgery(baseline)
measure: Quality of Recovery Score - 40 (QoR-40) after surgry
timeFrame: 1 day after the surgery
measure: The severity of pain at baseline
timeFrame: 1 day before the surgery(baseline)
measure: The severity of pain after surgry
timeFrame: From day 0 to up to 3 days after the surgery
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Junli Cao
state: Jiangsu
Study officials:
References: