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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Cranial Nerve Diseases

Intervention / Treatment
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* Other: Group Isolated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria ASA 1-3 Glasgow Coma Scale(GCS) >14 Exclusion Criteria: Glasgow Coma Scale(GCS) <14 Patients who do not understand the questions, not awake Patient who treated with hormones Patient with infection or inflammatory disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomize
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Isolated<br>Group Isolated (Group II) (eyes closed with patch and ear plugged; between 24:00-06:00) | Other: Group Isolated<br>* Eyes closed with patch and ears plugged between 24:00-06:00<br>|
| No Intervention: Group Disrupted<br>Group Disrupted (Group I) (exposed to ambient light and noise) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melatonin, Interleukin, Transcranial, Surgery, Intensive care