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Clinical Trials/NCT06178939
NCT06178939
Not yet recruiting
Not Applicable

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

Yonsei University1 site in 1 country60 target enrollmentDecember 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Stenosis
Sponsor
Yonsei University
Enrollment
60
Locations
1
Primary Endpoint
incidence of postoperative delirium
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2023
End Date
October 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

incidence of postoperative delirium

Time Frame: from postoperative day 0 to postoperative day 7

Confusion assessment methods(CAM) will be used to assess postoperative 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, including hallucinations, restlessness, calling out, slowed movement, or lethargy; and emotional disturbances, such as anxiety, irritability, euphoria, apathy, unpredictable mood shift, and personality changes).

Secondary Outcomes

  • type of delirium(from postoperative day 0 to postoperative day 7)
  • comprehensive geriatric assessment(CGA),(from postoperative day 0 to postoperative day 7)
  • duration of delirium(from postoperative day 0 to postoperative day 7)
  • total score of QOR-40(from postoperative day 0 to postoperative day 7)

Study Sites (1)

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