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NCT Number: NCT06467552

Effects of Nutritional Support on Postoperative Delirium

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.

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Key information

Conditions

Postoperative Delirium Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health system, Severance Hospital

Seoul, 03722, South Korea

Location status: Recruiting

Location contact

bon nyeo koo, MD

CONTACT

[email protected]

82-10-9982-4469

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control Group

Procedure

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

Nucare Curact group

Dietary Supplement

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 outcomes

  1. incidence of postoperative delirium

    Time frame: 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 :

    • Acute onset and fluctuating course Determined by collateral history or repeated clinic assessment
    • Inattention Counting from 20-1 is a simple (if blunt) test for this
    • Disorganized thinking
    • Altered levels of consciousness

Secondary outcomes

  1. duration of delirium

    Time frame: from postoperative day 0 to postoperative day 7

    The Quality of Recovery-40 (QoR-40) : 40~200(better recovery)

  2. type of delirium

    Time frame: from postoperative day 0 to postoperative day 7

  3. K-FRAIL for frailty

    Time frame: 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.

  4. GDS for depression

    Time frame: 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.

  5. ADL for independence

    Time frame: 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.

  6. SNSB-c for cognitive dysfunction

    Time frame: 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.

  7. QOR-40 for recovery

    Time frame: from postoperative day 0 to postoperative day 7

    The Quality of Recovery-40 (QoR-40) : 40~200(better recovery)

  8. K-MoCA for cognitive dysfunction

    Time frame: from postoperative day 0 to postoperative day 7

    Korean-Montreal Cognitive Assessment(K-MoCA) : 0~30, cognitive dysfunction<23.

  9. IADL for independence

    Time frame: from postoperative day 0 to postoperative day 7

    Instrumental Activities of Daily Living(IADL)-Lawton-Brody Scale : 0~8(complete independence).

Study contacts

Contact information is provided by the study sponsor or research team.

Bon-Nyeo koo, MD

CONTACT

[email protected]

82-10-9982-4469

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Effects of Nutritional Support on Postoperative Delirium (POD) in Elderly Non-cardiac Surgical patients_non-inferiority Comparison

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 21, 2024
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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