Anxiety Clinical Trial
Official title:
The Role of Endogenous Melatonin Levels on Preoperative and Postoperative Anxiety in Living Liver Donors
Verified date | January 2020 |
Source | Inonu University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Inonu university | Malatya |
Lead Sponsor | Collaborator |
---|---|
Inonu University | The Scientific and Technological Research Council of Turkey |
Turkey,
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
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 |
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