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

Primary Purpose

Sleep Deprivation

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dimming of lights and decreasing noise level
Bupivacaine (Bustesin®) via Pain Buster ® system
Tramadol HCl (Tramosel®) via PCA system (Gemstar®)
Major abdominal surgery
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Deprivation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing elective major abdominal surgery

Exclusion Criteria:

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

Sites / Locations

  • Eskisehir Osmangazi UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care

Dimming of lights and decreasing noise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

the effect of sleep quality on the postoperative urine 6-sulphatoxymelatonin (µg - micrograms) levels
the effect of sleep quality on the postoperative serum c-reactive protein (mg/l - milligram/liter) levels
the effect of sleep quality on the postoperative serum interleukin-1 and interleukin-6 (pg/ml - picograms/milliliter) levels

Secondary Outcome Measures

Full Information

First Posted
June 28, 2016
Last Updated
June 5, 2017
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT02824770
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 30, 2017 (Anticipated)
Study Completion Date
July 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dimming of lights and decreasing noise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dimming of lights and decreasing noise level
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Bupivacaine (Bustesin®) via Pain Buster ® system
Intervention Description
Patients will receive continous infusion of Bupivacaine (Bustesin®) via Pain Buster ® system into the wound at a rate of 5cc/hour
Intervention Type
Drug
Intervention Name(s)
Tramadol HCl (Tramosel®) via PCA system (Gemstar®)
Intervention Description
Patients will receive infusion of Tramadol HCl (Tramosel®) via patient-controlled analgesia system (Gemstar®)
Intervention Type
Procedure
Intervention Name(s)
Major abdominal surgery
Intervention Description
Any major abdominal surgery (e.g. colectomy, gastrectomy)
Primary Outcome Measure Information:
Title
the effect of sleep quality on the postoperative urine 6-sulphatoxymelatonin (µg - micrograms) levels
Time Frame
within 3 days after surgery
Title
the effect of sleep quality on the postoperative serum c-reactive protein (mg/l - milligram/liter) levels
Time Frame
within 3 days after surgery
Title
the effect of sleep quality on the postoperative serum interleukin-1 and interleukin-6 (pg/ml - picograms/milliliter) levels
Time Frame
within 3 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Necdet F Yasar, MD
Phone
+90 533 7218406
Email
nfyasar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Necdet F Yasar, MD
Organizational Affiliation
Eskisehir Osmangazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskisehir Osmangazi University
City
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enver Ihtiyar, Professor
Email
eihtiyar@ogu.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19578832
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.
Results Reference
background
PubMed Identifier
20398302
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.
Results Reference
background
PubMed Identifier
25477861
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.
Results Reference
background

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

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