: Association of Melatonin Levels and Light and Noise Isolation in ICU
NCT ID: NCT03659760
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2018-09-03
2019-04-25
Brief Summary
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In this study, it is planned to investigate the effect of sleep disruptions on melatonin levels and inflammation parameters in intensive care patients underwent transcranial surgery
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Detailed Description
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Patients will be randomly allocated by a computer generated random numbers list into two groups.
Patients with sleep disruptions (Group I) (exposed to ambient light and noise) and Patients without sleep disruptions (Group II) (eyes closed with patch and ear plugged; between 24:00-06:00)
Melatonin levels will be measured by urine 6-sulfatoxymelatonin (a-MT6) levels, which is a product of melatonin degradation at 07:00 am preoperative and postoperative day 1 and day 3.
Plasma Interleukin-1 (IL-1), Interleukin- 6 (IL-6),C-reactive protein (CRP) levels will be measured at 07:00 am preoperative and postoperative day 1and day 3.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Group Isolated
Group Isolated (Group II) (eyes closed with patch and ear plugged; between 24:00-06:00)
Group Isolated
Eyes closed with patch and ears plugged between 24:00-06:00
Group Disrupted
Group Disrupted (Group I) (exposed to ambient light and noise)
No interventions assigned to this group
Interventions
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Group Isolated
Eyes closed with patch and ears plugged between 24:00-06:00
Eligibility Criteria
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Inclusion Criteria
* Glasgow Coma Scale(GCS) \>14
Exclusion Criteria
* Patients who do not understand the questions, not awake
* Patient who treated with hormones
* Patient with infection or inflammatory disease
18 Years
65 Years
ALL
No
Sponsors
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Diskapi Yildirim Beyazit Education and Research Hospital
OTHER_GOV
Responsible Party
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Emine Arik
Specialist in Anesthesia
Principal Investigators
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Emine Arık
Role: PRINCIPAL_INVESTIGATOR
Dr
Locations
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Universty of Health Sciences, Dıskapı Yıldırım Beyazıt Training and Research Hospital
Ankara, , Turkey (Türkiye)
Countries
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References
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Grima NA, Rajaratnam SMW, Mansfield D, Sletten TL, Spitz G, Ponsford JL. Efficacy of melatonin for sleep disturbance following traumatic brain injury: a randomised controlled trial. BMC Med. 2018 Jan 19;16(1):8. doi: 10.1186/s12916-017-0995-1.
Yasar NF, Badak B, Canik A, Bas SS, Uslu S, Oner S, Ates E. Effects of Sleep Quality on Melatonin Levels and Inflammatory Response after Major Abdominal Surgery in an Intensive Care Unit. Molecules. 2017 Sep 12;22(9):1537. doi: 10.3390/molecules22091537.
Osier N, McGreevy E, Pham L, Puccio A, Ren D, Conley YP, Alexander S, Dixon CE. Melatonin as a Therapy for Traumatic Brain Injury: A Review of Published Evidence. Int J Mol Sci. 2018 May 22;19(5):1539. doi: 10.3390/ijms19051539.
Kurdi MS, Patel T. The role of melatonin in anaesthesia and critical care. Indian J Anaesth. 2013 Mar;57(2):137-44. doi: 10.4103/0019-5049.111837.
Other Identifiers
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EmineMelatonin
Identifier Type: -
Identifier Source: org_study_id
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