NCT03659760

: Association of Melatonin Levels and Light and Noise Isolation in ICU

Does Light and Noise Isolation Change the Melatonin Levels and Inflammatory Response After Cranial Surgery in an Intensive Care Unit

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Cranial Nerve Diseases

Interventions

Type	Name	Description
OTHER	Group Isolated	Eyes closed with patch and ears plugged between 24:00-06:00

Timeline

• Start date: 2018-09-03
• Primary completion: 2019-04-08
• Completion: 2019-04-25
• First posted: 2018-09-06
• Last updated: 2025-02-11

Locations

1 site across 1 country: Turkey (Türkiye)