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

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Deprivation
• Intervention / Treatment: Drug: Bupivacaine (Bustesin®) via Pain Buster ® system; Drug: Tramadol HCl (Tramosel®) via PCA system (Gemstar®); Procedure: Major abdominal surgery; Behavioral: Dimming of lights and decreasing noise level

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Eskisehir, Turkey, 26480
    • Recruiting
    • Eskisehir Osmangazi University
    • Contact: Enver Ihtiyar, Professor; Email: eihtiyar@ogu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing elective major abdominal surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Usual Care; 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; Patients will receive continous infusion of Bupivacaine (Bustesin®) via Pain Buster ® system into the wound at a rate of 5cc/hour; Drug: 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)
EXPERIMENTAL: Dimming of lights and decreasing noise; 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.	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; Drug: 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); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University
• Investigators: Principal Investigator: Necdet F Yasar, MD, Eskisehir Osmangazi University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ANTICIPATED): June 30, 2017
• Study Completion (ANTICIPATED): July 1, 2017

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (ESTIMATE): July 7, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2017
• Last Update Submitted That Met QC Criteria: June 5, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Sleep Deprivation; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Tramadol
• Other Study ID Numbers: 2016-1309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No