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Clinical Trials in South Korea / NCT06467552
Recruiting Not applicable

Effects of Nutritional Support on Postoperative Delirium

NCT06467552 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yonsei University
Phase
Not applicable
Started
2024-06
Last updated
2024-06-21

Condition(s) studied

Postoperative Delirium

Investigational drug(s) / intervention(s)

control groupNucare Curact group

control group: The entire process is carried out according to Severance Hospital surgical protocols.

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • incidence of postoperative delirium — from postoperative day 0 to postoperative day 7
    Confusion assessment methods(CAM) will be used for diagnosing delirium At least two times a day during the hospitalization period. Patients diagnosed with delirium using the CAM were evaluated for the duration, symptoms, and type of delirium (e.g., reduced awareness of the environment; poor cognitive skills; behavioral changes; and emotional disturbances). \*\* Confusion assessment methods(CAM) diagnostic algorism (positive or negative result, positive means delirium) CAM is considered positive if features 1 and 2 are present, with at least one of features 3 or 4. Below are the four criteria of features : 1. Acute onset and fluctuating course Determined by collateral history or repeated clinic assessment 2. Inattention Counting from 20-1 is a simple (if blunt) test for this 3. Disorganized thinking 4. Altered levels of consciousness

Trial sites (1)

FacilityCityRegionStatus
Yonsei University Health system, Severance Hospital Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06467552 on ClinicalTrials.gov ↗ ← All trials in South Korea