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

Cranial Nerve Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03659760
• Other study ID #: EmineMelatonin
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cranial Nerve Diseases
• Nervous System Diseases

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