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

NCT03659760 | Completed

• 1 other identifier: EmineMelatonin
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Conditions

Cranial Nerve Diseases

Keywords

Melatonin; Interleukin; Transcranial; Surgery; Intensive care

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• IL-1,IL-6,CRP

  : 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

Study Arms (2)

Group Isolated

EXPERIMENTAL

Group Isolated (Group II) (eyes closed with patch and ear plugged; between 24:00-06:00)

Other: Group Isolated

Group Disrupted

NO INTERVENTION

Group Disrupted (Group I) (exposed to ambient light and noise)

Interventions

Group Isolated OTHER

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

Group Isolated

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1-3
• Glasgow Coma Scale(GCS) \>14

You may not qualify if:

• 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

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

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

Ankara, Turkey (Türkiye)

Location

Related 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.

  PMID: 29347988 BACKGROUND

• 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.

  PMID: 28895895 BACKGROUND

• 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.

  PMID: 29786658 BACKGROUND

• 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.

  PMID: 23825812 BACKGROUND

MeSH Terms

Conditions

Cranial Nerve Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Emine Arık

  Dr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Anesthesia

Model Details: prospective randomize

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 6, 2018
• Study Start: September 3, 2018
• Primary Completion: April 8, 2019
• Study Completion: April 25, 2019
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

TU (1)