Effects of Cognitive Intervention Therapy on Postoperative Delirium

Not Applicable

Not yet recruiting

• Conditions: Spinal Stenosis; Disc Herniation; Lung Neoplasms; Carcinoma, Hepatocellular

• Registration Number: NCT06178939
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12
• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2023-12-15
• Last Update Submitted: 2023-12-15
• Study First Posted: 2023-12-21
• Last Update Posted: 2023-12-21
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
incidence of postoperative delirium	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 Outcome Measures

Name	Time	Method
comprehensive geriatric assessment(CGA),	from postoperative day 0 to postoperative day 7	Core component of CGA are as follows : functional capacity, fall risk, cognition, mood, polypharmacy, social support, financial concerns, goals of care, and advance care preferences.
duration of delirium	from postoperative day 0 to postoperative day 7
total score of QOR-40	from postoperative day 0 to postoperative day 7	The Quality of Recovery-40 (QoR-40) is a commonly utilized self-assessment questionnaire designed for postoperative patients. This survey is self-administered and aims to gather feedback from individuals about the quality of their recovery in the postoperative phase.; The QoR-40 is divided into categories such as emotional status, physical comfort, psychological support, physical independence, and pain. Max score of QoR-40 is 200.
type of delirium	from postoperative day 0 to postoperative day 7

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of