Clinical trial NCT02824770: Effects of Sleep Quality on Melatonin Levels and Inflammatory Response After Major Abdominal Surgery
Official title: Effects of Sleep Quality on Melatonin Levels and Inflammatory Response After Major Abdominal Surgery in an Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Deprivation
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endogenous melatonin is produced by the pineal gland at night under normal conditions and regulates the sleep-wake cycle. Artificial light administered at night suppresses melatonin production and sleep disturbances are accompanied by abnormal melatonin secretion such as phase delay. Therefore, dramatic disturbances of endogenous rhythms in intensive care unit patients have remarkable effects on melatonin production. In addition to its physiological roles in regulating sleep patterns, melatonin has been demonstrated to provide antiinflammatory effects in experimental models. Although some previous studies have investigated the circadian pattern of melatonin in intensive care unit patients, the investigators think that the present study is the first one that will assess the effects of controlling noise and light on melatonin and inflammatory response after major abdominal surgery.

Detailed description: This study is going to be conducted in accordance with the Helsinki Declaration and has been approved by Eskisehir Osmangazi University Ethics Committee. Forty consecutive patients, aged 18-65, who will undergo elective major abdominal operations will be enrolled in the study after obtaining informed consent. All patients will receive adequate postoperative pain management with the Pain Buster ® system and patient-controlled intravenous analgesia (PCA). The patients will be randomly assigned to either the experimental group or the control group. The control group will receive the usual care. The patients in the experimental group will be screened in the side-rooms where normally the patients who either have infections or are at risk of infection, are nursed. The study intervention will include dimming the lights to 40 lux and closing the doors of the side-room to decrease the noise level below 40 decibels (dB) between 11:00 p.m.-5:00 a.m.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective major abdominal surgery

Exclusion Criteria:

* Any evidence of inflammatory diseases during the postoperative care (e.g. anastomotic leakage)

Primary outcomes:
measure: the effect of sleep quality on the postoperative urine 6-sulphatoxymelatonin (µg - micrograms) levels
timeFrame: within 3 days after surgery
measure: the effect of sleep quality on the postoperative serum c-reactive protein (mg/l - milligram/liter) levels
timeFrame: within 3 days after surgery
measure: the effect of sleep quality on the postoperative serum interleukin-1 and interleukin-6 (pg/ml - picograms/milliliter) levels
timeFrame: within 3 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University
Study officials:
affiliation: Eskisehir Osmangazi University
name: Necdet F Yasar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Riutta A, Ylitalo P, Kaukinen S. Diurnal variation of melatonin and cortisol is maintained in non-septic intensive care patients. Intensive Care Med. 2009 Oct;35(10):1720-7. doi: 10.1007/s00134-009-1565-6. Epub 2009 Jul 4.
citation: Hu RF, Jiang XY, Zeng YM, Chen XY, Zhang YH. Effects of earplugs and eye masks on nocturnal sleep, melatonin and cortisol in a simulated intensive care unit environment. Crit Care. 2010;14(2):R66. doi: 10.1186/cc8965. Epub 2010 Apr 18.
citation: Seifman MA, Gomes K, Nguyen PN, Bailey M, Rosenfeld JV, Cooper DJ, Morganti-Kossmann MC. Measurement of serum melatonin in intensive care unit patients: changes in traumatic brain injury, trauma, and medical conditions. Front Neurol. 2014 Nov 17;5:237. doi: 10.3389/fneur.2014.00237. eCollection 2014.