PostoperAtive Neurocognitive Dysfunction After Major AbdomiNal Surgery (PANDAMAN)

Elective Major Abdominal Surgery Clinical Trial

— PANDAMAN  

Official title:

Postoperative Neurocognitive Dysfunction After Major Abdominal Surgery: A Prospective Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06182215
• Other study ID #: 2023-143-v2
• Status: Recruiting
• Start date: December 11, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Xiangcai Ruan, MD, PhD
• Phone: +86-13760710099
• Email: ruanxc[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Elective Major Abdominal Surgery

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital of Sun Yet-set University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of delirium during first 7 days after surgery	The result of 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) is positive.	Consecutive 7 days after the surgery or hospital discharge, whichever comes first.
Secondary	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.	Day 1 before surgery
Secondary	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.	Day 1 before surgery
Secondary	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.	Day 1 before surgery, day 3 after surgery
Secondary	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.	Within 15 minutes after induction of anesthesia, day 3 after surgery
Secondary	Preoperative Sleep quality	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.	Day 1 before surgery, Day 3 after surgery
Secondary	Postoperative pain	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.	Consecutive 7 days after the surgery or hospital discharge, whichever comes first.
Secondary	Length of hospital stay	The length of patient hospital stay will be supplemented through Hospital Information System after surgery.	Up to 24 weeks after surgery
Secondary	Health status and quality of life	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.	Day 1 before surgery, day 30 after surgery
Secondary	Postoperative adverse complications	Include but limited to hospital readmissions 30 days after surgery, unplaned reoperations, stroke, kidney failure, and wound infections.	Up to day 30 after surgery
Secondary	All-cause mortality at 30 days after surgery	The ratio of total deaths from all causes to the population.	Up to day 30 after surgery
Secondary	Postoperative cognitive dysfunction	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.	Day 1 before surgery, day 30 after surgery, day 90 after surgery