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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02824770
Enrollment
40
Registered
2016-07-07
Start date
2017-01-01
Completion date
2017-07-01
Last updated
2017-06-07

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

Conditions

Sleep Deprivation

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.

Interventions

BEHAVIORALDimming of lights and decreasing noise level

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

DRUGBupivacaine (Bustesin®) via Pain Buster ® system

Patients will receive continous infusion of Bupivacaine (Bustesin®) via Pain Buster ® system into the wound at a rate of 5cc/hour

DRUGTramadol HCl (Tramosel®) via PCA system (Gemstar®)

Patients will receive infusion of Tramadol HCl (Tramosel®) via patient-controlled analgesia system (Gemstar®)

PROCEDUREMajor abdominal surgery

Any major abdominal surgery (e.g. colectomy, gastrectomy)

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing elective major abdominal surgery

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
the effect of sleep quality on the postoperative urine 6-sulphatoxymelatonin (µg - micrograms) levelswithin 3 days after surgery
the effect of sleep quality on the postoperative serum c-reactive protein (mg/l - milligram/liter) levelswithin 3 days after surgery
the effect of sleep quality on the postoperative serum interleukin-1 and interleukin-6 (pg/ml - picograms/milliliter) levelswithin 3 days after surgery

Countries

Turkey (Türkiye)

Contacts

Primary ContactNecdet F Yasar, MD
nfyasar@gmail.com+90 533 7218406

Outcome results

None listed

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