PostoperAtive Neurocognitive Dysfunction After Major AbdomiNal Surgery (PANDAMAN)
- Conditions
- Elective Major Abdominal Surgery
- Registration Number
- NCT06182215
- Lead Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Brief Summary
Predisposing and precipitating factors for perioperative delirium for the elderly remain elusive. This research will be conducted to determine risk factors of postoperative delirium.
- Detailed Description
This study intends to include 500 participants over 65 years old undergoing elective abdominal major surgery. The primary outcome is incidence of delirium at 7 days postoperatively, and the secondary outcomes include preoperative sleep disorders(Athens In-somnia Scale, AIS), postoperative cognitive impairment (Abbreviated Mental Test Score, AMTS), postoperative pain (NRS pain score), incidence of significant postoperative complications, length of hospital stay, and serum biomarkers levels.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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;
- 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;
- Positive for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or symptomatic (e.g. fever, cough, loss of taste/smell);
- The cognitive assessment cannot be completed because the subject is blind, deaf, or unable to communicate in the local language;
- Long-term follow-up unavailable (homelessness, active psychosis or substance abuse).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of delirium during first 7 days after surgery Consecutive 7 days after the surgery or hospital discharge, whichever comes first. The result of 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) is positive.
- Secondary Outcome Measures
Name Time Method Postoperative pain Consecutive 7 days after the surgery or hospital discharge, whichever comes first. Postoperative pain will be evaluated by Number Rating Scale, which is composed of 11 numbers from 0 to 10, where 0 is no pain or hurt and 10 is the most or worst pain. The higher the number, the more severe the pain.
Length of hospital stay Up to 24 weeks after surgery The length of patient hospital stay will be supplemented through Hospital Information System after surgery.
All-cause mortality at 30 days after surgery Up to day 30 after surgery The ratio of total deaths from all causes to the population.
Preoperative cognitive function Day 1 before surgery 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.
Preoperative Sleep quality Day 1 before surgery, Day 3 after surgery Athens Insomnia Scale will be used to assess the patient's preoperative sleep quality. A maximum total score of 24 indicates the most severe symptoms of insomnia, while a cut-off point of ≥6 represents a minimum criterion for the confirmation of insomnia symptoms.
Health status and quality of life Day 1 before surgery, day 30 after surgery Short Form 36 Health Survey will be used to estimate the health status and quality of life of patients. This scale includes 8 dimensions and a total of 36 questions, convert the scores of each section into a range of 0 to 100, where 100 represents the "best health state", and the lower the score, the worse the health condition.
Serum biomakers levels Within 15 minutes after induction of anesthesia, day 3 after surgery 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.
Postoperative adverse complications Up to day 30 after surgery Include but limited to hospital readmissions 30 days after surgery, unplaned reoperations, stroke, kidney failure, and wound infections.
Age-adjusted Charlson Comorbidity Index Day 1 before surgery 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.
Preoperative anxiety Day 1 before surgery, day 3 after surgery 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.
Postoperative cognitive dysfunction Day 1 before surgery, day 30 after surgery, day 90 after surgery The Abbreviated Mental Test Score will be administered by telephone respectively 1 month and 3 months after surgery to identify long-term cognitive consequences of anaesthesia and postoperative delirium. The scale consists of 10 questions with a total of 10 points, the higher the score, the better the cognitive function, and those with score \< 8 will be identified as possible neurocognitive dysfunction.
Trial Locations
- Locations (1)
The Sixth Affiliated Hospital of Sun Yet-set University
🇨🇳Guangzhou, Guangdong, China