Comparison of the Incidence of Delirium Caused by Different Anesthetic Agents in Patients Undergoing Liver Transplantation

Recruiting

• Conditions: Hepatocellular Carcinoma; Liver Cirrhosis

• Registration Number: NCT06767579
• Lead Sponsor: Yonsei University

Brief Summary

This study is a prospective observational study that analyzes the incidence of postoperative delirium in patients undergoing liver transplantation, based on the use of the inhalational anesthetic sevoflurane and the intravenous anesthetic propofol.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-24
• Study First Submitted: 2024-11-28
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2027-10-28
• Study Completion: 2028-10-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Adults aged 19 years and older
• Patients undergoing liver transplantation who are scheduled to receive anesthesia with the inhaled anesthetic sevoflurane or the intravenous anesthetic propofol.

Exclusion Criteria

• Individuals with hearing loss, cognitive impairment or obvious dementia, hepatic encephalopathy, or difficulty in communication.
• Diagnosed with neurological disorders (e.g., brain hemorrhage, stroke, dementia, Parkinson's disease, cognitive impairment, etc.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of postoperative delirium	from postoperative day 0 to postoperative day 7	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; and emotional disturbances).; \*\* Confusion assessment methods(CAM) diagnostic algorism (positive or negative result, positive means delirium); CAM is considered positive if features 1 and 2 are present, with at least one of features 3 or 4. Below are the four criteria of features : 1. Acute onset and fluctuating course Determined by collateral history or repeated clinic assessment; 2. Inattention Counting from 20-1 is a simple (if blunt) test for this; 3. Disorganized thinking; 4. Altered levels of consciousness

Secondary Outcome Measures

Name	Time	Method
comprehensive geriatric assessment(CGA)	Participants will be followed for the duration of their hospital stay and until their visit within one month after discharge, with an expected average of 4 weeks	Core component of CGA are as follows : The Korean version of the fatigue, resistance, ambulation, illnesses, and loss of weight (K-FRAIL) scale : 0(healthy)\~8(frail) Mini Nutritional Assessment(MNA) : 0 (malnutrition)\~14(normal) Geriatric Depression Scale(GDS) : 0(normal)\~ 15(depression) Instrumental Activities of Daily Living(IADL)-Lawton-Brody Scale : 0\~8(complete independence)
duration of delirium	Participants will be followed for the duration of their hospital stay and until their visit within one month after discharge, with an expected average of 4 weeks	Duration of Delirium: The duration of delirium is measured from the onset to the resolution of symptoms, recorded in hours or days (e.g., 1 day, 3 days, 5 days).
total score of QOR-40	Participants will be followed for the duration of their hospital stay and until their visit within one month after discharge, with an expected average of 4 weeks	The Quality of Recovery-40 (QoR-40) 40\~200(better recovery)
type of delirium	Participants will be followed for the duration of their hospital stay and until their visit within one month after discharge, with an expected average of 4 weeks	Type of Delirium: Delirium is classified into three types: hyperactive, hypoactive, and mixed.

Trial Locations

Locations (1)

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