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

NCT02824770 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-06-07

No results posted yet for this study

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.

Conditions

  • Sleep Deprivation

Interventions

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)

Sponsors & Collaborators

  • Eskisehir Osmangazi University

    lead OTHER

Principal Investigators

  • Necdet F Yasar, MD · Eskisehir Osmangazi University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2017-06-30
Completion
2017-07-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02824770 on ClinicalTrials.gov