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

• Conditions: Elective Non-Cardiac Surgery; Postoperative Delirium
• Interventions: Diagnostic Test: Neuropsychological tests

• Registration Number: NCT03915314
• Lead Sponsor: Xuzhou Medical University

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 .

Study Timeline

• Status Verified: 2019-04
• Study Start: 2019-04-01
• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-04-11
• Last Update Submitted: 2019-04-11
• Study First Posted: 2019-04-16
• Last Update Posted: 2019-04-16
• Primary Completion: 2020-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-POD group	Neuropsychological tests	Non-POD refered to the patients who did not become delirious by the Confusion Assessment Method.
POD group	Neuropsychological tests	POD group refers to the patients who were diagnosed to be delirious by the Confusion Assessment Method.

Primary Outcome Measures

Name	Time	Method
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
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 neuronal injury	baseline, postoperative day 1	Neurofilament light (NfL) to be measured at 2 time points

Secondary Outcome Measures

Name	Time	Method
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).
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.
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.

Trial Locations

Locations (1)

Junli Cao; 🇨🇳 Xuzhou, Jiangsu, China