Recruiting NCT06467552
Effects of Nutritional Support on Postoperative Delirium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: control group, Nucare Curact group.
- Who it may be relevant to
- Registry conditions: Postoperative Delirium. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Nutritional Support on Postoperative Delirium (POD) in Elderly Non-cardiac Surgical patients_non-inferiority Comparison
Overview
This study is a prospective, single-center, randomized controlled trial to compare whether applying nutritional supplementation therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium.
Interventions
- Procedure control group
The entire process is carried out according to Severance Hospital surgical protocols. - Dietary supplement Nucare Curact group
The entire process is carried out according to Severance Hospital surgical protocols. The patients of control group will receive education from the research team about the importance of nutrition and exercise before and after surgery. In addition, the patients of control group will be instructed to take up to 4 doses of the nutritional supplement (Nucare Curact provided by DAESANG Wellife Inc.) per day for approximately 2 weeks before surgery and for about 4 weeks after surgery.
Primary outcome measures
- incidence of postoperative delirium [Time frame: from postoperative day 0 to postoperative day 7]
Secondary outcome measures (9)
- duration of delirium [Time frame: from postoperative day 0 to postoperative day 7]
- type of delirium [Time frame: from postoperative day 0 to postoperative day 7]
- K-FRAIL for frailty [Time frame: from postoperative day 0 to postoperative day 7]
- GDS for depression [Time frame: from postoperative day 0 to postoperative day 7]
- ADL for independence [Time frame: from postoperative day 0 to postoperative day 7]
- SNSB-c for cognitive dysfunction [Time frame: from postoperative day 0 to postoperative day 7]
- QOR-40 for recovery [Time frame: from postoperative day 0 to postoperative day 7]
- K-MoCA for cognitive dysfunction [Time frame: from postoperative day 0 to postoperative day 7]
- IADL for independence [Time frame: from postoperative day 0 to postoperative day 7]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
South Korea · 1 center
- Yonsei University Health system, Severance Hospital — Seoul
Identifiers
NCT: NCT06467552 · 4-2024-0324