Melatonin and Cardiac Outcome After Major Surgery

Melatonin and Cardiac Morbidity After Elective Abdominal Aortic Aneurism Repair

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00315926

Enrollment

Registered

2006-04-19

Start date

2007-01-31

Completion date

2008-07-31

Last updated

2010-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm

Keywords

Cardiac morbidity, Melatonin, Surgery, Postoperative

Brief summary

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

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.

Interventions

DRUGMelatonin

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

DRUGPlacebo

a mixture of ethanol and physiological saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Cardiac morbidity	30 days	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.

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026