Effects of Nutritional Support on Postoperative Delirium

Not Applicable

Recruiting

• Conditions: Postoperative Delirium

• 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

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-20
• Study Start: 2024-06
• Study First Submitted QC: 2024-06-17
• Last Update Submitted: 2024-06-17
• Study First Posted: 2024-06-21
• Last Update Posted: 2024-06-21
• Primary Completion: 2028-05-12
• Study Completion: 2028-05-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 314

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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