Understanding delirium risk after major abdominal surgery in older adults
Postoperative Neurocognitive Dysfunction After Major Abdominal Surgery: A Prospective Observational Cohort Study
This study looks at what might increase the risk of confusion after major abdominal surgery in older adults to help improve their care and recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 65 Years to 90 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06182215 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65 to 90 who are scheduled for elective major abdominal surgery lasting over two hours.
Not a fit: Patients with severe cognitive impairment, renal or liver failure, or those who have had recent major surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prevention and management strategies for postoperative delirium in older adults.
How similar studies have performed: Other studies have explored postoperative delirium in elderly patients, indicating a growing body of evidence, but this specific approach may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.