Hepatocellular CarcinomaNCT06767579
Comparison of the Incidence of Delirium Caused by Different Anesthetic Agents in Patients Undergoing Liver Transplantation
An observational study of Hepatocellular Carcinoma and Liver Cirrhosis, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cirrhosis
- Type of treatment
- Injection or infusion
- How many people
- 350 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Oct 2024to 17 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine
Seoul
Bon-Nyeo Koo, MD, PhD., 02-2227-7897, koobn@yuhs.ac
About this study
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.
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from postoperative day 0 to postoperative day 7
Secondary outcomes (4)
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)
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start24 Oct 2024
- Primary completion28 Oct 2027 (estimated)
- Study completion17 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767579
- Sponsor's protocol ID
- 4-2024-1084
- Status last verified
- Jan 2025
- First submitted
- 28 Nov 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Incidence of Delirium Caused by Different Anesthetic Agents in Patients Undergoing Liver Transplantation
- ClinicalTrials.gov ID
- NCT06767579
- Acronym / sponsor ID
- 4-2024-1084
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 28 Oct 2027 (estimated)
- Study completion
- 17 Oct 2028 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane Inhalation Anesthesia Group | – | –Sevoflurane Inhalation Anesthesia Group in Liver Transplantation Patients |
| Propofol Intravenous Anesthesia Group | – | –Propofol Intravenous Anesthesia Group in Liver Transplantation Patients |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 : 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
4 secondary outcomes
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Liver Cirrhosis, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative delirium (time frame: from postoperative day 0 to postoperative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.