Effects of Nutritional Support on Postoperative Delirium
- Conditions
- Postoperative Delirium
- Interventions
- Procedure: control groupDietary Supplement: Nucare Curact group
- Registration Number
- NCT06467552
- Lead Sponsor
- Yonsei University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 314
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group control group The entire process is carried out according to Severance Hospital surgical protocols. intervention group 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
Name Time Method 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
- Secondary Outcome Measures
Name Time Method GDS for depression from postoperative day 0 to postoperative day 7 Geriatric Depression Scale(GDS) : 0(normal)\~ 15(depression). A raw score is standardized. A lower score means cognitive dysfunction.
IADL for independence from postoperative day 0 to postoperative day 7 Instrumental Activities of Daily Living(IADL)-Lawton-Brody Scale : 0\~8(complete independence).
duration of delirium from postoperative day 0 to postoperative day 7 The Quality of Recovery-40 (QoR-40) : 40\~200(better recovery)
type of delirium from postoperative day 0 to postoperative day 7 K-FRAIL for frailty from postoperative day 0 to postoperative day 7 The Korean version of the fatigue, resistance, ambulation, illnesses, and loss of weight (K-FRAIL) scale : 0(healthy)\~8(frail).
A raw score is standardized. A lower score means cognitive dysfunction.ADL for independence from postoperative day 0 to postoperative day 7 Activities of Daily Living(ADL)-Barthel Index : 0(completely dependent )\~105( independent).
A raw score is standardized. A lower score means cognitive dysfunction.QOR-40 for recovery from postoperative day 0 to postoperative day 7 The Quality of Recovery-40 (QoR-40) : 40\~200(better recovery)
SNSB-c for cognitive dysfunction from postoperative day 0 to postoperative day 7 Seoul Neuropsychological Screening Battery-Core(SNSB-C): total score is 617. A raw score is standardized. A lower score means cognitive dysfunction.
K-MoCA for cognitive dysfunction from postoperative day 0 to postoperative day 7 Korean-Montreal Cognitive Assessment(K-MoCA) : 0\~30, cognitive dysfunction\<23.
Trial Locations
- Locations (1)
Yonsei University Health system, Severance Hospital
🇰🇷Seoul, Korea, Republic of