Clinical trial NCT04230707: Endogenous Melatonin Levels on Anxiety in Living Liver Donors
Official title: The Role of Endogenous Melatonin Levels on Preoperative and Postoperative Anxiety in Living Liver Donors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplantation
Anxiety
Melatonin
Lead sponsor: Inonu University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2020-01-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The correlation between anxiety and melatonin levels
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu university
Study officials:
References:
citation: 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.