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

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

Study Overview

• Status: Completed
• Conditions: Cranial Nerve Diseases
• Intervention / Treatment: Other: Group Isolated

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Universty of Health Sciences, Dıskapı Yıldırım Beyazıt Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Melatonin level	Melatonin will be measured urine 6-sulphatoxymelatonin	At preoperative 07:00 am
Melatonin level	Melatonin will be measured urine 6-sulphatoxymelatonin	07:00 am postoprative day 1
Melatonin level	Melatonin will be measured urine 6-sulphatoxymelatonin	07:00 am postoprative day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
• Investigators: Principal Investigator: Emine Arık, Dr

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2018
• Primary Completion (Actual): April 8, 2019
• Study Completion (Actual): April 25, 2019

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Melatonin; Surgery; Intensive care; Interleukin; Transcranial
• Additional Relevant MeSH Terms: Nervous System Diseases; Cranial Nerve Diseases
• Other Study ID Numbers: EmineMelatonin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No