Nutritional support to reduce postoperative delirium in elderly patients
Effects of Nutritional Support on Postoperative Delirium (POD) in Elderly Non-cardiac Surgical patients_non-inferiority Comparison
This study is testing if giving extra nutrition to older patients before and after non-heart surgery can help reduce confusion and delirium after their operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 314 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06467552 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, single-center, randomized controlled trial aimed at evaluating the effects of nutritional supplementation therapy on elderly patients aged 65 and older who are undergoing non-cardiac surgery. The trial will compare a control group with a group receiving nutritional support before and after surgery to determine if this intervention can lower the incidence of postoperative delirium. Participants must be able to take oral intake starting from the first postoperative day and are expected to undergo surgeries lasting two hours or more under general anesthesia.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 65 and older scheduled for non-cardiac major surgeries lasting two hours or more.
Not a fit: Patients with uncontrolled systemic conditions, cognitive impairments, or neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of postoperative delirium in elderly patients, improving their recovery and overall outcomes.
How similar studies have performed: While there is ongoing research in nutritional support for surgical patients, this specific approach targeting postoperative delirium in elderly patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Elderly patients aged 65 and above. * Patients undergoing non-cardiac major surgery in thoracic surgery, lung cancer surgery, multi-level spinal surgery in neurosurgery and orthopedics, or liver cancer surgery in hepatobiliary and pancreatic surgery, under general anesthesia with an expected surgery duration of 2 hours or more. * Patients scheduled for arterial catheterization. * Patients who are able to take oral intake from postoperative day #1. Exclusion Criteria: * Patients with uncontrolled systemic conditions such as diabetes, hypertension, renal disease, liver disease, and other systemic illnesses. * Those with visual impairment. * Patients with cognitive impairment based on the Mini-Mental State Examination for Dementia Screening criteria. * Individuals experiencing difficulty in communication. * Those diagnosed with neurological disorders (such as brain hemorrhage, stroke, brain tumor, dementia, Parkinson's disease, cognitive impairment, depression, etc.). * Patients diagnosed with alcohol or substance addiction. * Patients with cancelled scheduled surgeries. * Patients undergoing minor surgeries with expected anesthesia durations of less than 2 hours.
Where this trial is running
Seoul
- Yonsei University Health system, Severance Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Bon-Nyeo koo, MD
- Email: koobn@yuhs.ac
- Phone: 82-10-9982-4469
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.