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Not yet recruiting NCT06178939

Effects of Cognitive Intervention Therapy on Postoperative Delirium

No phase Interventional Spinal Stenosis Disc Herniation Lung Neoplasms Carcinoma, Hepatocellular

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: control group, intervention group.
Who it may be relevant to
Registry conditions: Spinal Stenosis, Disc Herniation, Lung Neoplasms, Carcinoma, Hepatocellular. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Cognitive Intervention Therapy on Postoperative Delirium in Elderly Non-cardiac Surgical Patients

Overview

This study is a prospective, single-center, randomized controlled trial to compare whether applying cognitive intervention therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium compared to conservative treatment.

Interventions

  • 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.
  • Procedure intervention group
    For the intervention group, the entire process is carried out according to the Severance Hospital surgical protocol, and the research team provides education before surgery on the importance of nutrition and exercise before and after surgery. In addition, the cognitive training program developed by Rowan is taught with the goal of performing it for at least 10 hours before the surgery, it is conducted the training program after the surgery.

Primary outcome measures

  • incidence of postoperative delirium [Time frame: from postoperative day 0 to postoperative day 7]
Secondary outcome measures (4)
  • comprehensive geriatric assessment(CGA), [Time frame: from postoperative day 0 to postoperative day 7]
  • duration of delirium [Time frame: from postoperative day 0 to postoperative day 7]
  • type of delirium [Time frame: from postoperative day 0 to postoperative day 7]
  • total score of QOR-40 [Time frame: from postoperative day 0 to postoperative day 7]

Eligibility criteria

Inclusion criteria

  • Elderly patients aged 65 and above.
  • Patients undergoing orthopedic, thoracic, or hepatopancreatobiliary surgery under general anesthesia with an expected surgery duration of 2 hours or more.
  • Patients scheduled for arterial catheterization.

Exclusion criteria

  • Patients with uncontrolled systemic conditions such as diabetes and hypertension.
  • Those with visual impairment.
  • Patients with cognitive impairment based on the MMSE-DS 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

South Korea · 1 center
  • Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine — Seoul

Identifiers

NCT: NCT06178939 · 4-2023-0872

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗