An interventional study of control group and Nucare Curact group in Postoperative Delirium, sponsored by Yonsei University. Recruiting at 1 site in Korea, Republic of. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by Yonsei University · Not applicable, Interventional, and Other
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's planned enrollment of 314 is above the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The entire process is carried out according to Severance Hospital surgical protocols.
Procedure: control 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.
Dietary Supplement: Nucare Curact group
The entire process is carried out according to Severance Hospital surgical protocols.
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.
incidence of postoperative delirium
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
Time frame: from postoperative day 0 to postoperative day 7
duration of delirium
The Quality of Recovery-40 (QoR-40) : 40\~200(better recovery)
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
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.
Time frame: from postoperative day 0 to postoperative day 7
GDS for depression
Geriatric Depression Scale(GDS) : 0(normal)\~ 15(depression). A raw score is standardized. A lower score means cognitive dysfunction.
Time frame: from postoperative day 0 to postoperative day 7
ADL for independence
Activities of Daily Living(ADL)-Barthel Index : 0(completely dependent )\~105( independent). A raw score is standardized. A lower score means cognitive dysfunction.
Time frame: from postoperative day 0 to postoperative day 7
SNSB-c for cognitive dysfunction
Seoul Neuropsychological Screening Battery-Core(SNSB-C): total score is 617. A raw score is standardized. A lower score means cognitive dysfunction.
Time frame: from postoperative day 0 to postoperative day 7
QOR-40 for recovery
The Quality of Recovery-40 (QoR-40) : 40\~200(better recovery)
Time frame: from postoperative day 0 to postoperative day 7
K-MoCA for cognitive dysfunction
Korean-Montreal Cognitive Assessment(K-MoCA) : 0\~30, cognitive dysfunction\<23.
Time frame: from postoperative day 0 to postoperative day 7
IADL for independence
Instrumental Activities of Daily Living(IADL)-Lawton-Brody Scale : 0\~8(complete independence).
Time frame: from postoperative day 0 to postoperative day 7
Plan to share: No
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Yonsei University