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

NCT ID: NCT02824770

Last Updated: 2017-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2017-07-01

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.

Conditions

Sleep Deprivation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Bupivacaine (Bustesin®) via Pain Buster ® system

Intervention Type: DRUG

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®)

Intervention Type: DRUG

Patients will receive infusion of Tramadol HCl (Tramosel®) via patient-controlled analgesia system (Gemstar®)

Major abdominal surgery

Intervention Type: PROCEDURE

Any major abdominal surgery (e.g. colectomy, gastrectomy)

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.

Group Type: EXPERIMENTAL

Dimming of lights and decreasing noise level

Intervention Type: BEHAVIORAL

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

Bupivacaine (Bustesin®) via Pain Buster ® system

Intervention Type: DRUG

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®)

Intervention Type: DRUG

Patients will receive infusion of Tramadol HCl (Tramosel®) via patient-controlled analgesia system (Gemstar®)

Major abdominal surgery

Intervention Type: PROCEDURE

Any major abdominal surgery (e.g. colectomy, gastrectomy)

Interventions

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

Intervention Type: BEHAVIORAL

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

Intervention Type: DRUG

Tramadol HCl (Tramosel®) via PCA system (Gemstar®)

Patients will receive infusion of Tramadol HCl (Tramosel®) via patient-controlled analgesia system (Gemstar®)

Intervention Type: DRUG

Major abdominal surgery

Any major abdominal surgery (e.g. colectomy, gastrectomy)

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eskisehir Osmangazi University

OTHER

Sponsor Role: lead

Responsible Party

Necdet Fatih Yasar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Necdet F Yasar, MD

Role: PRINCIPAL_INVESTIGATOR

Eskisehir Osmangazi University

Locations

Eskisehir Osmangazi University

Eskişehir, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Necdet F Yasar, MD

Role: CONTACT

nfyasar@gmail.com

+90 533 7218406

Facility Contacts

Enver Ihtiyar, Professor

Role: primary

eihtiyar@ogu.edu.tr

References

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.

Reference Type: BACKGROUND

PMID: 19578832 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20398302 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25477861 (View on PubMed)

Other Identifiers

2016-1309

Identifier Type: -

Identifier Source: org_study_id