Melatonin and Cardiac Outcome After Major Surgery

University Hospital, Gentofte, Copenhagen52 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Aortic Aneurysm

Interventions

MelatoninDRUG

Melatonin 50 mg during surgery and 10 mg every night for 3 nights

PlaceboDRUG

a mixture of ethanol and physiological saline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte

Hellerup, Denmark

Outcomes

Primary Outcomes

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.

Time frame: 30 days

Secondary Outcomes

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

Time frame: 3 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.