Liver TransplantationNCT04230707
Endogenous Melatonin Levels on Anxiety in Living Liver Donors
An observational study of Liver Transplantation and Anxiety, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Interesting in living liver donor transplantation have greatly increased because of inadequacy of cadaveric organs and the inability to supply the growing need for cadaveric transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Transplantation, Anxiety, Melatonin
- What is being tested?
- Endogenous Melatonin Levels
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 60 Living liver donors (no= 60), between the ages of 18-65, ASA (American Society of Anesthesiologists Classification) 1-2 scheduled for right hepatectomy.
Who may be able to join
- Living liver donors, scheduled for right hepatectomy.
- between the ages of 18-65,
- American Society of Anesthesiologists Classification (ASA) 1-2
Who cannot join
- Patients with cardiovascular,
- neurological
- psychiatric disorders,
- opioid tolerance,
- sleep disturbance,
- hypnotic, neuroleptic, antidepressant, beta blocker and steroid use
- allergy history were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Endogenous Melatonin Levels on Preoperative and Postoperative Anxiety in Living Liver Donors
Interesting in living liver donor transplantation have greatly increased because of inadequacy of cadaveric organs and the inability to supply the growing need for cadaveric transplantation. Surgical procedures applied to living liver donors do not only physically demand organs, but can also cause psychological burden. It has been reported that melatonin had antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative and analgesic properties. It was shown to administration of exogenous melatonin has been increase sedation and decrease anxiety in the preoperative period compared to placebo.
The aim of this study; To investigate preoperative and postoperative anxiety levels of CKV and to exam the relationship between anxiety levels and endogenous melatonin levels.
Read the detailed description
Interesting in living liver donor (LLD) transplantation have greatly increased because of inadequacy of cadaveric organs and the inability to supply the growing need for cadaveric transplantation. Surgical procedures applied to LLD do not only physically demand organs, but can also cause psychological burden. Preoperative anxiety is seen in 60-80% of patients scheduled for surgery. It has been reported that melatonin had antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative and analgesic properties. It was shown to administration of exogenous melatonin has been increase sedation and decrease anxiety in the preoperative period compared to placebo.
The aim of this study; To investigate preoperative and postoperative anxiety levels of LLD and to exam the relationship between anxiety levels and endogenous melatonin levels.
This prospective clinical study will perform at Inonu University Liver Transplant Institute. Anxiety of the patients included in the study will be measure with Spielberger State Anxiety Scale Scale (STAI FORM TX-1) in preoperative and postoperative period. It was designed to assess levels of state anxiety and traint anxiety, through 40 items scored by a likert-scale. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale. Patients without premedication will admit to the operating room. Before induction of anesthesia, the vascular access will perform and 3 mL of blood sample will take to check for preoperative melatonin level. Standard general anesthesia will perform to all donors. At the end of surgery, the patients will take to intensive care unit. After 24 hours, blood samples will take for post-melatonin. Plasma melatonin concentrations will measure using High Performance Liquid Chromatography (HPLC) method in Inonu University Faculty of Pharmacy Analytical Chemistry Department research laboratory.
- Conditions
- Liver Transplantation, Anxiety, Melatonin
- Being tested
- Endogenous Melatonin Levels
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endogenous Melatonin LevelsOther
High Endogenous Melatonin Levels is Group 1 Low Endogenous Melatonin Levels is group 2
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between anxiety and melatonin levels
Melatonin is a hormone secreted from the pineal gland. It shows a daily biorhythm. The circadian rhythm of melatonin changes according to age and it's production decreases with older ages. Melatonin level can be measured in the blood and in urine collected for 24 hours.It was designed to assess levels of state anxiety and traint anxiety, through 40 items scored by a likert-scale. the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Oct 2019
- Primary completion15 Feb 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Inonu 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 only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Mehmet Ali Erdoğan, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230707
- Sponsor's protocol ID
- MAE6
- Other IDs
- 217S871
- Status last verified
- Jan 2020
- First submitted
- 14 Oct 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altunkaya N, Erdogan MA, Ozgul U, Sanli M, Ucar M, Ozhan O, Sumer F, Erdogan S, Colak C, Durmus M. Changes in Melatonin, Cortisol, and Body Temperature, and the Relationship Between Endogenous Melatonin Levels and Analgesia Consumption in Patients Undergoing Bariatric Surgery. Obes Surg. 2018 Oct;28(10):3186-3192. doi: 10.1007/s11695-018-3313-x.
PubMed 29785473
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Endogenous Melatonin Levels on Preoperative and Postoperative Anxiety in Living Liver Donors
- ClinicalTrials.gov ID
- NCT04230707
- Acronym / sponsor ID
- MAE6
- Conditions
- Liver Transplantation, Anxiety, Melatonin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 15 Feb 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 18 Jan 2020 (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.
Interesting in living liver donor transplantation have greatly increased because of inadequacy of cadaveric organs and the inability to supply the growing need for cadaveric transplantation. Surgical procedures applied to living liver donors do not only physically demand organs, but can also cause psychological burden. It has been reported that melatonin had antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative and analgesic properties. It was shown to administration of exogenous melatonin has been increase sedation and decrease anxiety in the preoperative period compared to placebo.
The aim of this study; To investigate preoperative and postoperative anxiety levels of CKV and to exam the relationship between anxiety levels and endogenous melatonin levels.
Detailed description
Interesting in living liver donor (LLD) transplantation have greatly increased because of inadequacy of cadaveric organs and the inability to supply the growing need for cadaveric transplantation. Surgical procedures applied to LLD do not only physically demand organs, but can also cause psychological burden. Preoperative anxiety is seen in 60-80% of patients scheduled for surgery. It has been reported that melatonin had antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative and analgesic properties. It was shown to administration of exogenous melatonin has been increase sedation and decrease anxiety in the preoperative period compared to placebo.
The aim of this study; To investigate preoperative and postoperative anxiety levels of LLD and to exam the relationship between anxiety levels and endogenous melatonin levels.
This prospective clinical study will perform at Inonu University Liver Transplant Institute. Anxiety of the patients included in the study will be measure with Spielberger State Anxiety Scale Scale (STAI FORM TX-1) in preoperative and postoperative period. It was designed to assess levels of state anxiety and traint anxiety, through 40 items scored by a likert-scale. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale. Patients without premedication will admit to the operating room. Before induction of anesthesia, the vascular access will perform and 3 mL of blood sample will take to check for preoperative melatonin level. Standard general anesthesia will perform to all donors. At the end of surgery, the patients will take to intensive care unit. After 24 hours, blood samples will take for post-melatonin. Plasma melatonin concentrations will measure using High Performance Liquid Chromatography (HPLC) method in Inonu University Faculty of Pharmacy Analytical Chemistry Department research laboratory.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 60 Living liver donors (no= 60), between the ages of 18-65, ASA (American Society of Anesthesiologists Classification) 1-2 scheduled for right hepatectomy.
Key inclusion criteria (3 listed)
- Living liver donors, scheduled for right hepatectomy.
- between the ages of 18-65,
- American Society of Anesthesiologists Classification (ASA) 1-2
Key exclusion criteria (7 listed)
- Patients with cardiovascular,
- neurological
- psychiatric disorders,
- opioid tolerance,
- sleep disturbance,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endogenous Melatonin LevelsHigh Endogenous Melatonin Levels is Group 1 Low Endogenous Melatonin Levels is group 2 | Other | – |
Primary outcome
The correlation between anxiety and melatonin levels
Time frame: up to 24 hours
Melatonin is a hormone secreted from the pineal gland. It shows a daily biorhythm. The circadian rhythm of melatonin changes according to age and it's production decreases with older ages. Melatonin level can be measured in the blood and in urine collected for 24 hours.It was designed to assess levels of state anxiety and traint anxiety, through 40 items scored by a likert-scale. the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Background: PubMed 29785473Altunkaya N, Erdogan MA, Ozgul U, Sanli M, Ucar M, Ozhan O, Sumer F, Erdogan S, Colak C, Durmus M. Changes in Melatonin, Cortisol, and Body Temperature, and the Relationship Between Endogenous Melatonin Levels and Analgesia Consumption in Patients Undergoing Bariatric Surgery. Obes Surg. 2018 Oct;28(10):3186-3192. doi: 10.1007/s11695-018-3313-x.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Liver Transplantation and Anxiety, run by Inonu University at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between anxiety and melatonin levels (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04230707, which also lists 1 linked publication.
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 18 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.