Clinical trial NCT06182215: PostoperAtive Neurocognitive Dysfunction After Major AbdomiNal Surgery (PANDAMAN)
Official title: Postoperative Neurocognitive Dysfunction After Major Abdominal Surgery: A Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Elective Major Abdominal Surgery
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 65 to 90 years who received elective major abdominal surgery (estimated operation time over 2 hours)

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Incidence of delirium during first 7 days after surgery
timeFrame: Consecutive 7 days after the surgery or hospital discharge, whichever comes first.
Secondary outcomes:
measure: Preoperative cognitive function
timeFrame: Day 1 before surgery
measure: Age-adjusted Charlson Comorbidity Index
timeFrame: Day 1 before surgery
measure: Preoperative anxiety
timeFrame: Day 1 before surgery, day 3 after surgery
measure: Serum biomakers levels
timeFrame: Within 15 minutes after induction of anesthesia, day 3 after surgery
measure: Preoperative Sleep quality
timeFrame: Day 1 before surgery, Day 3 after surgery
measure: Postoperative pain
timeFrame: Consecutive 7 days after the surgery or hospital discharge, whichever comes first.
measure: Length of hospital stay
timeFrame: Up to 24 weeks after surgery
measure: Health status and quality of life
timeFrame: Day 1 before surgery, day 30 after surgery
measure: Postoperative adverse complications
timeFrame: Up to day 30 after surgery
measure: All-cause mortality at 30 days after surgery
timeFrame: Up to day 30 after surgery
measure: Postoperative cognitive dysfunction
timeFrame: Day 1 before surgery, day 30 after surgery, day 90 after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yet-set University
state: Guangdong
Study officials:
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: Xiangcai Ruan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: