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
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
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Universty of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital | Ankara |
Lead Sponsor | Collaborator |
---|---|
Diskapi Yildirim Beyazit Education and Research Hospital |
Turkey,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT01932255 -
CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap
|
N/A |