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

NCT02824770 | Unknown

• 1 other identifier: 2016-1309
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Deprivation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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; Drug: Tramadol HCl (Tramosel®) via PCA system (Gemstar®); Procedure: Major abdominal surgery

Dimming of lights and decreasing noise

EXPERIMENTAL

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; Drug: Bupivacaine (Bustesin®) via Pain Buster ® system; Drug: Tramadol HCl (Tramosel®) via PCA system (Gemstar®); Procedure: Major abdominal surgery

Interventions

Dimming of lights and decreasing noise level 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

Dimming of lights and decreasing noise

Bupivacaine (Bustesin®) via Pain Buster ® system DRUG

Patients will receive continous infusion of Bupivacaine (Bustesin®) via Pain Buster ® system into the wound at a rate of 5cc/hour

Dimming of lights and decreasing noise; Usual Care

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

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

Dimming of lights and decreasing noise; Usual Care

Major abdominal surgery PROCEDURE

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

Dimming of lights and decreasing noise; Usual Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective major abdominal surgery

You may not qualify if:

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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, 26480, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 19578832 BACKGROUND

• 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.

  PMID: 20398302 BACKGROUND

• 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.

  PMID: 25477861 BACKGROUND

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Bupivacaine; Tramadol

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids

Study Officials

• Necdet F Yasar, MD

  Eskisehir Osmangazi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Necdet F Yasar, MD

CONTACT

+90 533 7218406; nfyasar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 7, 2016
• Study Start: January 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: July 1, 2017
• Last Updated: June 7, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)