Understanding delirium risk after major abdominal surgery in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify risk factors associated with postoperative delirium in elderly patients undergoing elective major abdominal surgery. It will enroll 500 participants aged 65 and older, monitoring them for the incidence of delirium seven days post-surgery. Secondary outcomes will include assessments of preoperative sleep disorders, postoperative cognitive impairment, pain levels, significant complications, length of hospital stay, and serum biomarker levels. The findings could help improve patient care and outcomes in this vulnerable population.

Why it matters

Who can join: the full rules

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).

Where it's running

• The Sixth Affiliated Hospital of Sun Yet-set University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Xiangcai Ruan, MD, PhD — Sixth Affiliated Hospital, Sun Yat-sen University
• Study coordinator: Xiangcai Ruan, MD, PhD
• Email: ruanxc@mail.sysu.edu.cn
• Phone: +86-13760710099

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.