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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03659760
Recruitment Status : Unknown
Verified August 2018 by Emine Arik, Diskapi Yildirim Beyazit Education and Research Hospital.
Recruitment status was:  Recruiting
First Posted : September 6, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Emine Arik, Diskapi Yildirim Beyazit Education and Research Hospital

Study Description
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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


Condition or disease Intervention/treatment Phase
Cranial Nerve Diseases Other: Group Isolated Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective randomize
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Does Light and Noise Isolation Change the Melatonin Levels and Inflammatory Response After Cranial Surgery in an Intensive Care Unit
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise
Drug Information available for: Melatonin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group Isolated
Group Isolated (Group II) (eyes closed with patch and ear plugged; between 24:00-06:00)
 Other: Group Isolated
Eyes closed with patch and ears plugged between 24:00-06:00
No Intervention: Group Disrupted
Group Disrupted (Group I) (exposed to ambient light and noise)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659760


Contacts
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Contact: Emine Arık +905333471530 emineincearik@yahoo.com
Contact: Emine Arık

Locations
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Turkey
Universty of Health Sciences, Dıskapı Yıldırım Beyazıt Training and Research Hospital Recruiting
Ankara, Turkey
Contact: Emine Arık    +90 533 3471530    emineincearik@yahoo.com   
Sponsors and Collaborators
Diskapi Yildirim Beyazit Education and Research Hospital
Investigators
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Principal Investigator: Emine Arık Dr
More Information
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Publications:

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Responsible Party: Emine Arik, Specialist in Anesthesia, Diskapi Yildirim Beyazit Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03659760    
Other Study ID Numbers: EmineMelatonin
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emine Arik, Diskapi Yildirim Beyazit Education and Research Hospital:
Melatonin
Interleukin
Transcranial
Surgery
Intensive care
Additional relevant MeSH terms:
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Nervous System Diseases
Cranial Nerve Diseases