Effects of Nutritional Support on Postoperative Delirium

Yonsei University

Status: Enrolling

Conditions: Postoperative Delirium

Treatments: Dietary Supplement: Nucare Curact group; Procedure: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06467552

4-2024-0324

Details and patient eligibility

About

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.

Enrollment: 314 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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314 participants in 2 patient groups

control group

Active Comparator group

Description:

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

Treatment:

Procedure: control group

intervention group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Nucare Curact group