Effects of Cognitive Intervention Therapy on Postoperative Delirium

NCT06178939 | Not Yet Recruiting DMC

• 1 other identifier: 4-2023-0872
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Stenosis; Disc Herniation; Lung Neoplasms; Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• incidence of postoperative delirium

  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).

  from postoperative day 0 to postoperative day 7

Secondary Outcomes (4)

• comprehensive geriatric assessment(CGA),

  from postoperative day 0 to postoperative day 7

• duration of delirium

  from postoperative day 0 to postoperative day 7

• type of delirium

  from postoperative day 0 to postoperative day 7

• total score of QOR-40

  from postoperative day 0 to postoperative day 7

Study Arms (2)

control group

ACTIVE COMPARATOR

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: control group

intervention group

EXPERIMENTAL

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.

Procedure: intervention group

Interventions

control group PROCEDURE

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.

control group

intervention group PROCEDURE

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.

intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Spinal Stenosis; Intervertebral Disc Displacement; Lung Neoplasms; Carcinoma, Hepatocellular

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Bon-Nyeo Koo

  Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bon-Nyeo Koo, MD, PhD.

CONTACT

02-2227-7897; koobn@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 21, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)