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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis; Hepatocellular Carcinoma

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine
    • Contact: Bon-Nyeo Koo, MD, PhD.; Phone Number: 02-2227-7897; Email: koobn@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

• Adults aged 19 years or older
• Recipients of liver transplants who are scheduled to undergo anesthesia using the inhalation anesthetic sevoflurane or the intravenous anesthetic propofol

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Sevoflurane Inhalation Anesthesia Group; Sevoflurane Inhalation Anesthesia Group in Liver Transplantation Patients
Propofol Intravenous Anesthesia Group; Propofol Intravenous Anesthesia Group in Liver Transplantation Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of 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; 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 : Acute onset and fluctuating course Determined by collateral history or repeated clinic assessment; Inattention Counting from 20-1 is a simple (if blunt) test for this; Disorganized thinking; Altered levels of consciousness	from postoperative day 0 to postoperative day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comprehensive geriatric assessment(CGA)	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)	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	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).	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
total score of QOR-40	The Quality of Recovery-40 (QoR-40) 40~200(better recovery)	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	Type of Delirium: Delirium is classified into three types: hyperactive, hypoactive, and mixed.	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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2024
• Primary Completion (Estimated): October 28, 2027
• Study Completion (Estimated): October 17, 2028

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathologic Processes; Digestive System Diseases; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Liver Diseases; Fibrosis; Delirium; Liver Cirrhosis
• Other Study ID Numbers: 4-2024-1084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No