Melatonin and Cardiac Outcome After Major Surgery

Study Overview
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Brief Summary
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The purpose of this study is to assess whether treatment with melatonin can reduce cell damage and inflammatory stress response and thereby occurrence of myocardial injury after abdominal aortic surgery.

Detailed Description
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Abdominal aortic surgery is associated with a significant increase of oxidative and inflammatory stress response. Aortic surgery is also associated with elevated troponin which is a sensitive and specific marker for myocardial injury. The severity of oxidative stress is correlated with elevated troponin. Melatonin, which is a hormone produced in brain, seems to modify cell damage and inflammation. On the other hand we know, that melatonin production first night after surgery is disturbed. The purpose of this study is therefore to determine whether treatment with melatonin can reduce cell damage and inflammation, and thereby occurrence of myocardial injury associated with abdominal aortic surgery.

Official Title
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Melatonin and Cardiac Morbidity After Elective Abdominal Aortic Aneurism Repair

Conditions
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Aortic Aneurysm

Intervention / Treatment
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* Drug: Melatonin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for elective abdominal aortic aneurism surgery or periphery atheroscleroses with indicated protheses operation Patients between 18 and 80 years old Exclusion Criteria: Patients with ASA class > 3 Anticoagulation therapy (marevan and marcoumar) Preoperative therapy with opioid, anxiolytic and hypnotic medication Renal insufficient (preoperative creatinin > 200 mmol/l) Well-known liver insufficient Alcohol consumption (more than 5 drinks) Compliance (language difficulty, mental problems etc.) Pregnancy and breast-feeding Lack of written consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br> | Drug: Melatonin<br>* Melatonin 50 mg during surgery and 10 mg every night for 3 nights<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* a mixture of ethanol and physiological saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac morbidity | artrial fibrillation, unstable angina, myocardial infarction, ECG changes (T-wave inversion for more than 24 hours, new ST-segment depression for more than 24 hours, acute ST-segment elevation with appearance of q-waves or loss of R-waves, left bundle branch block), or a characteristic pattern of rising and falling values of troponin-I, or pulmonary oedema. Mortality was defined as any cause of death in the 30 days after surgery. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative and inflammatory stress response | Blood samples for analysis of malondialdehyde (MDA), ascorbic acid (AA), dehydroascorbic acid (DHA) and C-reactive protein (CRP) assessed before and after operation | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac morbidity, Melatonin, Surgery, Postoperative