Endogenous Melatonin Levels on Anxiety in Living Liver Donors

NCT04230707 | Unknown

• 2 other identifiers: MAE6217S871
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Liver Transplantation; Anxiety; Melatonin

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 24 hours

Interventions

Endogenous Melatonin Levels OTHER

High Endogenous Melatonin Levels is Group 1 Low Endogenous Melatonin Levels is group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Living liver donors, scheduled for right hepatectomy.
• between the ages of 18-65,
• American Society of Anesthesiologists Classification (ASA) 1-2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inonu University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Inonu university

Malatya, 044100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 29785473 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample was taken to check for preoperative melatonin level. Plasma melatonin concentrations were measured using HPLC method in Inonu University Faculty of Pharmacy Analytical Chemistry Department research laboratory.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr. Mehmet Ali Erdogan

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: January 18, 2020
• Study Start: October 1, 2019
• Primary Completion: February 15, 2020
• Study Completion: March 1, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)