NCT06767579

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Oct 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Oct 2024Oct 2028

Study Start

First participant enrolled

October 24, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2027

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2028

Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

3 years

First QC Date

November 28, 2024

Last Update Submit

January 8, 2025

Conditions

Hepatocellular CarcinomaLiver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • 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 : 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

    from postoperative day 0 to postoperative day 7

Secondary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Sevoflurane Inhalation Anesthesia Group

Sevoflurane Inhalation Anesthesia Group in Liver Transplantation Patients

Propofol Intravenous Anesthesia Group

Propofol Intravenous Anesthesia Group in Liver Transplantation Patients

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Cirrhosis

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2024

First Posted

January 10, 2025

Study Start

October 24, 2024

Primary Completion (Estimated)

October 28, 2027

Study Completion (Estimated)

October 17, 2028

Last Updated

January 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)