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

Diskapi Yildirim Beyazit Training and Research Hospital

Status: Completed

Conditions: Cranial Nerve Diseases

Treatments: Other: Group Isolated

Study type: Interventional

Funder types: Other

Identifiers

NCT03659760

EmineMelatonin

Details and patient eligibility

About

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

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 2 patient groups

Group Isolated

Experimental group

Description:

Group Isolated (Group II) (eyes closed with patch and ear plugged; between 24:00-06:00)

Treatment:

Other: Group Isolated

Group Disrupted

No Intervention group

Description:

Group Disrupted (Group I) (exposed to ambient light and noise)