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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03659760
Other study ID # EmineMelatonin
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 3, 2018
Est. completion date December 30, 2018

Study information

Verified date August 2018
Source Diskapi Yildirim Beyazit Education and Research Hospital
Contact Emine Arik
Phone +905333471530
Email emineincearik@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Universty of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Grima NA, Rajaratnam SMW, Mansfield D, Sletten TL, Spitz G, Ponsford JL. Efficacy of melatonin for sleep disturbance following traumatic brain injury: a randomised controlled trial. BMC Med. 2018 Jan 19;16(1):8. doi: 10.1186/s12916-017-0995-1. — View Citation

Kurdi MS, Patel T. The role of melatonin in anaesthesia and critical care. Indian J Anaesth. 2013 Mar;57(2):137-44. doi: 10.4103/0019-5049.111837. — View Citation

Osier N, McGreevy E, Pham L, Puccio A, Ren D, Conley YP, Alexander S, Dixon CE. Melatonin as a Therapy for Traumatic Brain Injury: A Review of Published Evidence. Int J Mol Sci. 2018 May 22;19(5). pii: E1539. doi: 10.3390/ijms19051539. Review. — View Citation

Yasar NF, Badak B, Canik A, Bas SS, Uslu S, Öner S, Ates E. Effects of Sleep Quality on Melatonin Levels and Inflammatory Response after Major Abdominal Surgery in an Intensive Care Unit. Molecules. 2017 Sep 12;22(9). pii: E1537. doi: 10.3390/molecules22091537. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Melatonin level Melatonin will be measured urine 6-sulphatoxymelatonin At preoperative 07:00 am
Primary Melatonin level Melatonin will be measured urine 6-sulphatoxymelatonin 07:00 am postoprative day 1
Primary Melatonin level Melatonin will be measured urine 6-sulphatoxymelatonin 07:00 am postoprative day 3
Secondary 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
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