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

Sleep Deprivation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02824770
• Other study ID #: 2016-1309
• Status: Recruiting
• Phase: N/A
• First received: June 28, 2016
• Last updated: June 5, 2017
• Start date: January 1, 2017
• Est. completion date: July 1, 2017

Study information

• Verified date: June 2017
• Source: Eskisehir Osmangazi University
• Contact: Necdet F Yasar, MD
• Phone: +90 533 7218406
• Email: nfyasar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 1, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients undergoing elective major abdominal surgery

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Behavioral:
• Dimming 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

Drug:
• Bupivacaine (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
• Tramadol HCl (Tramosel®) via PCA system (Gemstar®)
Patients will receive infusion of Tramadol HCl (Tramosel®) via patient-controlled analgesia system (Gemstar®)

Procedure:
• Major abdominal surgery
Any major abdominal surgery (e.g. colectomy, gastrectomy)

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

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