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Melatonin is secreted from the epiphyseal gland with a circadian rhythm and is known to be anti-inflammatory.
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
Patients with Glasgow coma scale (GKS) >14, American Society of Anesthesiologist (ASA) I-III, intensive care patients underwent transcranial surgery will be included
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Isolated | Experimental | Group Isolated (Group II) (eyes closed with patch and ear plugged; between 24:00-06:00) |
|
| Group Disrupted | No Intervention | Group Disrupted (Group I) (exposed to ambient light and noise) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Isolated | Other | Eyes closed with patch and ears plugged between 24:00-06:00 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Melatonin level | Melatonin will be measured urine 6-sulphatoxymelatonin | At preoperative 07:00 am |
| Melatonin level | Melatonin will be measured urine 6-sulphatoxymelatonin | 07:00 am postoprative day 1 |
| Melatonin level | Melatonin will be measured urine 6-sulphatoxymelatonin | 07:00 am postoprative day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| IL-1,IL-6,CRP | serum | : at 7 o'clock in the morning preoperative day, 7 in the morning on the first postoperative day and 7 in the morning on the third postoperative day hour |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emine Arık | Dr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universty of Health Sciences, Dıskapı Yıldırım Beyazıt Training and Research Hospital | Ankara | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29347988 | Background | 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. | |
| 28895895 | Background | 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. |
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| ID | Term |
|---|---|
| D003389 | Cranial Nerve Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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prospective randomize
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| 29786658 | Background | 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. |
| 23825812 | Background | 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. |