An interventional study of Group Isolated in Cranial Nerve Diseases, sponsored by Diskapi Yildirim Beyazit Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Diskapi Yildirim Beyazit Education and Research Hospital · Not applicable, Interventional, and Other
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.
974 studies on the registry are indexed under Nervous System Diseases; 252 are open to participants now.
This study's enrollment of 41 is below the median of 48 across 623 interventional studies indexed under Nervous System Diseases.
Browse Nervous System Diseases studies →Diskapi Yildirim Beyazit Education and Research Hospital is the lead sponsor of 66 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group Isolated (Group II) (eyes closed with patch and ear plugged; between 24:00-06:00)
Other: Group Isolated
Group Disrupted (Group I) (exposed to ambient light and noise)
Eyes closed with patch and ears plugged between 24:00-06:00
Melatonin level
Melatonin will be measured urine 6-sulphatoxymelatonin
Time frame: At preoperative 07:00 am
Melatonin level
Melatonin will be measured urine 6-sulphatoxymelatonin
Time frame: 07:00 am postoprative day 1
Melatonin level
Melatonin will be measured urine 6-sulphatoxymelatonin
Time frame: 07:00 am postoprative day 3
IL-1,IL-6,CRP
serum
Time frame: : 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
Plan to share: Undecided
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Diskapi Yildirim Beyazit Education and Research Hospital