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

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ClinicalTrials.gov Identifier: NCT02824770
Recruitment Status : Unknown
Verified June 2017 by Necdet Fatih Yasar, Eskisehir Osmangazi University.
Recruitment status was:  Recruiting
First Posted : July 7, 2016
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Necdet Fatih Yasar, Eskisehir Osmangazi University

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.

Condition or disease Intervention/treatment Phase
Sleep Deprivation 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Sleep Quality on Melatonin Levels and Inflammatory Response After Major Abdominal Surgery in an Intensive Care Unit
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : June 30, 2017
Estimated Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

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.
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

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)




Primary Outcome Measures :
  1. the effect of sleep quality on the postoperative urine 6-sulphatoxymelatonin (µg - micrograms) levels [ Time Frame: within 3 days after surgery ]
  2. the effect of sleep quality on the postoperative serum c-reactive protein (mg/l - milligram/liter) levels [ Time Frame: within 3 days after surgery ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing elective major abdominal surgery

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824770


Contacts
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Contact: Necdet F Yasar, MD +90 533 7218406 nfyasar@gmail.com

Locations
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Turkey
Eskisehir Osmangazi University Recruiting
Eskisehir, Turkey, 26480
Contact: Enver Ihtiyar, Professor       eihtiyar@ogu.edu.tr   
Sponsors and Collaborators
Eskisehir Osmangazi University
Investigators
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Principal Investigator: Necdet F Yasar, MD Eskisehir Osmangazi University
Publications:
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Responsible Party: Necdet Fatih Yasar, Assistant Professor, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier: NCT02824770    
Other Study ID Numbers: 2016-1309
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Deprivation
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Tramadol
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics