PostoperAtive Neurocognitive Dysfunction After Major AbdomiNal Surgery (PANDAMAN)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65-90
SponsorSixth Affiliated Hospital, Sun Yat-sen University

About this trial

Predisposing and precipitating factors for perioperative delirium for the elderly remain elusive. This research will be conducted to determine risk factors of postoperative delirium.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

65 to 90 years old to receive elective major abdominal surgery (expected operation time over 2 hours); ,

American society of Aneshesiologists(ASA)physical status I-III;

Disqualifiers

Mini-Mental State Examination (MMES) score < 15;

Renal failure (requiring dialysis) or liver failure (Child-Pugh score > 5);

Severe impairment due to structural or hypoxic brain injury, more than 2 days in ICU one month before surgery;

Underwent major heart, lung or abdominal surgery within 1 year;

Trial population

Patients aged 65 to 90 years who received elective major abdominal surgery (estimated operation time over 2 hours)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 1 trial group
Group A: Prospective observational cohorts

Trial outcomes

Primary outcomes

1

Incidence of delirium during first 7 days after surgery

The result of 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) is positive.

Time frame
Consecutive 7 days after the surgery or hospital discharge, whichever comes first.

Secondary outcomes

1

Preoperative cognitive function

The Mini-Mental State Examination scale will be used to assist in evaluating preoperative cognitive function in patients. The scale's testing items include orientation, memory, calculation, language, visual space, use, and attention, with a total score of 30. The higher the score, the better the cognitive function, and the score below 27 indicates possible cognitive impairment.

Time frame
Day 1 before surgery
2

Age-adjusted Charlson Comorbidity Index

Age-adjusted Charlson Comorbidity Index is a method used to evaluate the impact of multiple diseases on a patient's health status. The scale includes a total of 16 common co-morbidity diseases, which is divided into 4 categories according to different disease severity, with scores of 1,2,3 or 6. The higher the score, the more kinds of diseases the patient suffers at the same time, and their health status may be more complex and fragile.

Time frame
Day 1 before surgery
3

Preoperative anxiety

Hamilton Anxiety Scale will be used to evaluate the patient's anxiety status, which consist of 14 items. All items are scored on a 5-level scale of 0-4, with criteria for each level being none, mild, moderate, severe, and extremely severe. The higher the score, the more severe the anxiety symptoms.

Time frame
Day 1 before surgery, day 3 after surgery
4

Serum biomakers levels

Extract venous blood samples from the target patient, store and centrifuge the Samples appropriately. Quantitatively detect the serum biomakers levels, such as NFL, using enzyme-linked immunosorbent assay, and retest the concentration changes of these biomarkers 3 days after surgery.

Time frame
Within 15 minutes after induction of anesthesia, day 3 after surgery

Other outcomes

Sponsors and contacts

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