RecruitingNot Applicable

PostoperAtive Neurocognitive Dysfunction After Major AbdomiNal Surgery (PANDAMAN)

China500 participantsStarted 2023-12-11

Plain-language 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.

Who can participate

Age range

65 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of delirium during first 7 days after surgery

Timeframe: Consecutive 7 days after the surgery or hospital discharge, whichever comes first.

Trial details

NCT IDNCT06182215

SponsorSixth Affiliated Hospital, Sun Yat-sen University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

Contact for this trial

Xiangcai Ruan, MD, PhD

+86-13760710099 ruanxc@mail.sysu.edu.cn

View on ClinicalTrials.gov More Elective Major Abdominal Surgery trials