Clinical trial NCT03659760: : Association of Melatonin Levels and Light and Noise Isolation in ICU
Official title: Does Light and Noise Isolation Change the Melatonin Levels and Inflammatory Response After Cranial Surgery in an Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cranial Nerve Diseases
Keywords: Melatonin
Interleukin
Transcranial
Surgery
Intensive care
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-09-06
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomize
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Melatonin level
timeFrame: At preoperative 07:00 am
measure: Melatonin level
timeFrame: 07:00 am postoprative day 1
measure: Melatonin level
timeFrame: 07:00 am postoprative day 3
Secondary outcomes:
measure: IL-1,IL-6,CRP
timeFrame: : 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
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Universty of Health Sciences, Dıskapı Yıldırım Beyazıt Training and Research Hospital
Study officials:
affiliation: Dr
name: Emine Arık
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Yasar NF, Badak B, Canik A, Bas SS, Uslu S, Oner 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):1537. doi: 10.3390/molecules22091537.
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):1539. doi: 10.3390/ijms19051539.
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.