Status:
RECRUITING
PostoperAtive Neurocognitive Dysfunction After Major AbdomiNal Surgery (PANDAMAN)
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Elective Major Abdominal Surgery
Eligibility:
All Genders
65-90 years
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 ...
Eligibility Criteria
Inclusion
- 65 to 90 years old to receive elective major abdominal surgery (expected operation time over 2 hours); ,
- American society of Aneshesiologists（ASA）physical status I-III;
Exclusion
- Mini-Mental State Examination (MMES) score \< 15;
- Renal failure (requiring dialysis) or liver failure (Child-Pugh score \> 5);
- Severe impairment due to structural or hypoxic brain injury, more than 2 days in ICU one month before surgery;
- Underwent major heart, lung or abdominal surgery within 1 year;
- Positive for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or symptomatic (e.g. fever, cough, loss of taste/smell);
- The cognitive assessment cannot be completed because the subject is blind, deaf, or unable to communicate in the local language;
- Long-term follow-up unavailable (homelessness, active psychosis or substance abuse).
Key Trial Info
Start Date :
December 11 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06182215
Start Date
December 11 2023
End Date
December 31 2026
Last Update
June 17 2024
Active Locations (1)
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1
The Sixth Affiliated Hospital of Sun Yet-set University
Guangzhou, Guangdong, China, 510100