Melatonin and Cardiac Outcome After Major Surgery

University Hospital, Gentofte, Copenhagen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Aortic Aneurysm

Treatments: Drug: Melatonin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00315926

2612-3109

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

Melatonin

Experimental group

Treatment:

Drug: Melatonin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo