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Completed

NCT Number: NCT03659760

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

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

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Key information

Conditions

Cranial Nerve Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universty of Health Sciences, Dıskapı Yıldırım Beyazıt Training and Research Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group Isolated

Other

Eyes closed with patch and ears plugged between 24:00-06:00

Primary outcomes

  1. Melatonin level

    Time frame: At preoperative 07:00 am

    Melatonin will be measured urine 6-sulphatoxymelatonin

  2. Melatonin level

    Time frame: 07:00 am postoprative day 1

    Melatonin will be measured urine 6-sulphatoxymelatonin

  3. Melatonin level

    Time frame: 07:00 am postoprative day 3

    Melatonin will be measured urine 6-sulphatoxymelatonin

Secondary outcomes

  1. IL-1,IL-6,CRP

    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

    serum

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 6, 2018
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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