Endogenous Melatonin Levels on Anxiety in Living Liver Donors

Anxiety Clinical Trial

Official title:

The Role of Endogenous Melatonin Levels on Preoperative and Postoperative Anxiety in Living Liver Donors

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04230707
• Other study ID #: MAE6
• Secondary ID: 217S871
• Status: Enrolling by invitation
• Start date: October 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: January 2020
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: March 1, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Living liver donors, scheduled for right hepatectomy.

• between the ages of 18-65,

• American Society of Anesthesiologists Classification (ASA) 1-2

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Liver Transplantation
• Melatonin

Intervention

Other:
• Endogenous Melatonin Levels
High Endogenous Melatonin Levels is Group 1 Low Endogenous Melatonin Levels is group 2

Locations

Country	Name	City	State
Turkey	Inonu university	Malatya

Sponsors (2)

Lead Sponsor	Collaborator
Inonu University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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