Clinical trial NCT06467552: Effects of Nutritional Support on Postoperative Delirium
Official title: Effects of Nutritional Support on Postoperative Delirium (POD) in Elderly Non-cardiac Surgical patients_non-inferiority Comparison
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Delirium
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 314
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: incidence of postoperative delirium
timeFrame: from postoperative day 0 to postoperative day 7
Secondary outcomes:
measure: duration of delirium
timeFrame: from postoperative day 0 to postoperative day 7
measure: type of delirium
timeFrame: from postoperative day 0 to postoperative day 7
measure: K-FRAIL for frailty
timeFrame: from postoperative day 0 to postoperative day 7
measure: GDS for depression
timeFrame: from postoperative day 0 to postoperative day 7
measure: ADL for independence
timeFrame: from postoperative day 0 to postoperative day 7
measure: SNSB-c for cognitive dysfunction
timeFrame: from postoperative day 0 to postoperative day 7
measure: QOR-40 for recovery
timeFrame: from postoperative day 0 to postoperative day 7
measure: K-MoCA for cognitive dysfunction
timeFrame: from postoperative day 0 to postoperative day 7
measure: IADL for independence
timeFrame: from postoperative day 0 to postoperative day 7
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health system, Severance Hospital
Study officials:
References: