Elective Major Abdominal Surgery
Conditions
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.
Interventions
None listed
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. 65 to 90 years old to receive elective major abdominal surgery (expected operation time over 2 hours); , 2. American society of Aneshesiologists（ASA）physical status I-III;
Exclusion criteria
1. Mini-Mental State Examination (MMES) score \< 15; 2. Renal failure (requiring dialysis) or liver failure (Child-Pugh score \> 5); 3. Severe impairment due to structural or hypoxic brain injury, more than 2 days in ICU one month before surgery; 4. Underwent major heart, lung or abdominal surgery within 1 year; 5. Positive for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or symptomatic (e.g. fever, cough, loss of taste/smell); 6. The cognitive assessment cannot be completed because the subject is blind, deaf, or unable to communicate in the local language; 7. Long-term follow-up unavailable (homelessness, active psychosis or substance abuse).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactXiangcai Ruan, MD, PhD
Outcome results
None listed