PostoperAtive Neurocognitive Dysfunction After Major AbdomiNal Surgery (PANDAMAN)

Sun Yat-sen University

Status: Enrolling

Conditions: Elective Major Abdominal Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT06182215

2023-143-v2

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

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).

Trial design

500 participants in 1 patient group

Prospective observational cohorts

Description:

patients undergoing elective major abdominal surgery (estimated operation time over 2 hours)