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No effect of melatonin to modify surgical-stress response after major vascular surgery: a randomised placebo-controlled trial.

European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery
October 1, 2010
B Kücükakin et al. (6 authors)
Journal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine whether perioperative melatonin treatment could reduce oxidative and inflammatory stress markers in patients undergoing major vascular surgery.

Results Summary

Melatonin treatment did not significantly reduce oxidative or inflammatory stress parameters compared to placebo. The melatonin group reported significantly more side effects than the placebo group.

Population

Patients undergoing major vascular surgery.

Effective Dosage

Intra-operative intravenous infusion of 50 mg melatonin, followed by 10 mg melatonin orally for the first 3 nights after surgery.

Duration

Intra-operative infusion plus 3 days post-surgery.

Interactions

None mentioned

Extracted Claims (6)
InterventionDirectionEndpointPopulationDosageImpactClaim #
melatonin infusion during surgery and oral melatonin treatment for 3 days after surgery
no change
oxidative and inflammatory parameters
patients
no significant differences
did not reduce
#1
melatonin infusion during surgery and oral melatonin treatment for 3 days after surgery
no change
malondialdehyde (MDA)
patients
no significant differences
No significant differences were observed in
#2
melatonin infusion during surgery and oral melatonin treatment for 3 days after surgery
no change
ascorbic acid (AA)
patients
no significant differences
No significant differences were observed in
#3
melatonin infusion during surgery and oral melatonin treatment for 3 days after surgery
no change
dehydroascorbic acid (DHA)
patients
no significant differences
No significant differences were observed in
#4
melatonin infusion during surgery and oral melatonin treatment for 3 days after surgery
no change
C-reactive protein (CRP)
patients
no significant differences
No significant differences were observed in
#5
melatonin
increase
side effects
patients
significantly more
significantly more
#6
Abstract

BACKGROUND: A possible mechanism underlying cardiovascular morbidity after major vascular surgery may be the perioperative ischaemia-reperfusion with excessive oxygen-derived free-radical production and increased levels of circulating inflammatory mediators. We examined the effect of melatonin infusion during surgery and oral melatonin treatment for 3 days after surgery on biochemical markers of oxidative and inflammatory stress. METHODS: Patients received an intra-operative intravenous infusion of 50 mg melatonin or placebo. In addition, all patients received 10 mg melatonin or placebo orally the first 3 nights after surgery. Blood samples for analysis of malondialdehyde (MDA), ascorbic acid (AA), dehydroascorbic acid (DHA) and C-reactive protein (CRP) were collected preoperatively, and at 5 min, 6 h and 24 h after clamp removal (recirculation of the first leg). RESULTS: Twenty-six patients received melatonin and 24 patients received placebo. No significant differences were observed in any of the oxidative and inflammatory stress parameters. There were significantly more side effects in the melatonin group than in the placebo group. CONCLUSIONS: Melatonin treatment in the perioperative period did not reduce the oxidative and inflammatory parameters measured in this study.

Medical Subject Headings (MeSH)
Administration, OralAdolescentAdultAgedAged, 80 and overAnalysis of VarianceAscorbic AcidBiomarkersC-Reactive ProteinChi-Square DistributionChromatography, High Pressure LiquidDehydroascorbic AcidDouble-Blind MethodFemaleHumansInflammationInfusions, IntravenousMaleMalondialdehydeMelatoninMiddle AgedOxidative StressPlacebosStatistics, NonparametricTreatment OutcomeVascular Surgical Procedures
Study Links
Quality Scores
Safety70
Efficacy20/10
Quality80/10
Citation Metrics
Total Citations21
Citations/Year1.4
Relative Citation Ratio0.75
NIH Percentile40%
Research Impact Scores
APT Score0.50
Weight Score1.25
Normalized Score0.52
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