PostoperAtive Neurocognitive Dysfunction After Major Abdominal Surgery (PANDS) (PANDS)

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

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

Study Overview

• Status: Recruiting
• Conditions: Elective Major Abdominal Surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Xiangcai Ruan, MD, PhD; Phone Number: +86-13760710099; Email: ruanxc@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510100
      • Recruiting
      • The Sixth Affiliated Hospital of Sun Yet-set University
      • Contact: Mengying Ding, MD; Phone Number: +86-15170375679; Email: dingmy7@mails.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Prospective observational cohorts; patients undergoing elective major abdominal surgery (estimated operation time over 2 hours)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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.
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Investigators: Principal Investigator: Xiangcai Ruan, MD, PhD, Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 2, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2023-143-v2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No