: 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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03659760

Enrollment

Registered

2018-09-06

Start date

2018-09-03

Completion date

2019-04-25

Last updated

2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cranial Nerve Diseases

Keywords

Melatonin, Interleukin, Transcranial, Surgery, Intensive care

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.

Interventions

OTHERGroup Isolated

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Intervention model description

prospective randomize

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Melatonin level	At preoperative 07:00 am	Melatonin will be measured urine 6-sulphatoxymelatonin

Secondary

Measure	Time frame	Description
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	serum

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026