Effects of Sleep Quality on Melatonin Levels and Inflammatory Response After Major Abdominal Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Sleep Quality on Melatonin Levels and Inflammatory Response After Major Abdominal Surgery in an Intensive Care Unit

Conditions
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Sleep Deprivation

Intervention / Treatment
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* Behavioral: Dimming of lights and decreasing noise level
* Drug: Bupivacaine (Bustesin®) via Pain Buster ® system
* Drug: Tramadol HCl (Tramosel®) via PCA system (Gemstar®)
* Procedure: Major abdominal surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective major abdominal surgery Exclusion Criteria: Any evidence of inflammatory diseases during the postoperative care (e.g. anastomotic leakage)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>After a major abdominal surgery, the control group will receive the usual postoperative care including continous infusion of Bupivacaine (Bustesin®) via Pain Buster ® system into the wound at a rate of 5cc/hour and infusion of Tramadol HCl (Tramosel®) via PCA (Gemstar®) in the surgical intensive care unit. | Drug: Bupivacaine (Bustesin®) via Pain Buster ® system<br>* Patients will receive continous infusion of Bupivacaine (Bustesin®) via Pain Buster ® system into the wound at a rate of 5cc/hour<br>Drug: Tramadol HCl (Tramosel®) via PCA system (Gemstar®)<br>* Patients will receive infusion of Tramadol HCl (Tramosel®) via patient-controlled analgesia system (Gemstar®)<br>Procedure: Major abdominal surgery<br>* Any major abdominal surgery (e.g. colectomy, gastrectomy)<br>|
| Experimental: Dimming of lights and decreasing noise<br>After a major abdominal surgery, 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 and will receive continous infusion of Bupivacaine (Bustesin®) via Pain Buster ® system into the wound at a rate of 5cc/hour and infusion of Tramadol HCl (Tramosel®) via PCA (Gemstar®) as in the control group. The study intervention will include dimming of lights and decreasing noise. The lights will be dimmed to 40 lux. The doors of the side-rooms will be closed decrease the noise level below 40 dB between 11:00 p.m.-5:00 a.m. | Behavioral: Dimming of lights and decreasing noise level<br>* The study intervention will include dimming of lights and decreasing noise level. The lights will be dimmed to 40 lux and the doors of the side-room will be closed to decrease the noise level below 40 dB between 11:00 p.m.-5:00 a.m<br>Drug: Bupivacaine (Bustesin®) via Pain Buster ® system<br>* Patients will receive continous infusion of Bupivacaine (Bustesin®) via Pain Buster ® system into the wound at a rate of 5cc/hour<br>Drug: Tramadol HCl (Tramosel®) via PCA system (Gemstar®)<br>* Patients will receive infusion of Tramadol HCl (Tramosel®) via patient-controlled analgesia system (Gemstar®)<br>Procedure: Major abdominal surgery<br>* Any major abdominal surgery (e.g. colectomy, gastrectomy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effect of sleep quality on the postoperative urine 6-sulphatoxymelatonin (µg - micrograms) levels |  | within 3 days after surgery | 
| the effect of sleep quality on the postoperative serum c-reactive protein (mg/l - milligram/liter) levels |  | within 3 days after surgery | 
| the effect of sleep quality on the postoperative serum interleukin-1 and interleukin-6 (pg/ml - picograms/milliliter) levels |  | within 3 days after surgery |