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NCT Number: NCT06767579

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Fibrosis Liver Cirrhosis Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine

Seoul, South Korea

Location status: Recruiting

Location contact

Bon-Nyeo Koo, MD, PhD.

CONTACT

[email protected]

02-2227-7897

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Primary outcomes

  1. incidence of postoperative delirium

    Time frame: 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 :

    • 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

Secondary outcomes

  1. comprehensive geriatric assessment(CGA)

    Time frame: 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)

  2. duration of delirium

    Time frame: 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).

  3. total score of QOR-40

    Time frame: 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)

  4. type of delirium

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jan 10, 2025
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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