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

Not Applicable

Completed

• Conditions: Cranial Nerve Diseases
• Interventions: Other: Group Isolated

• Registration Number: NCT03659760
• Lead Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2018-08-31
• Study Start: 2018-09-03
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-06
• Primary Completion: 2019-04-08
• Study Completion: 2019-04-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Melatonin level	07:00 am postoprative day 3	Melatonin will be measured urine 6-sulphatoxymelatonin

Secondary Outcome Measures

Name	Time	Method
IL-1,IL-6,CRP	: 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	serum

Trial Locations

Locations (1)

Universty of Health Sciences, Dıskapı Yıldırım Beyazıt Training and Research Hospital; 🇹🇷 Ankara, Turkey