drugset / Trial / NCT02851433

Evaluate the Protective Effect of Conditioning With Sevoflurane on the Myocardium

NCT02851433 ↗

Phase 4 Completed 82 enrolled Centre Hospitalier Universitaire Dijon
RandomizedParallel-groupSingle-blindTreatment

Summary

Heart surgery is a considerable source of stress for the myocardium that must be minimized. Troponin Ic is a reliable marker to determine the level of this myocardial stress. Studies have shown that post-conditioning with AVH has a protective effect on the myocardium, if the treatment is initiated at the start of the ischemia. The aim of this study is to evaluate the protective effect on the myocardium (by measuring troponin levels) of the association of pre-conditioning and post-conditioning with Sevoflurane (AVH) sedation administered during and after scheduled surgery for valve replacement, via sternotomy or thoracotomy compared with total intravenous anaesthesia with Propofol.

Timeline

Start
2015-10-14
Primary completion
2017-08-29
Completion
2017-09-04

Outcome

Missed primary endpoint

paper The postoperative kinetics of cTnI did not differ significantly between groups: the mean difference was 0.44 ± 1.09 μg/ml, P = .69. PMID 33327246 ↗

paper The use of an anaesthesia and ICU sedation with sevoflurane was not associated with a lower incidence of myocardial injury assessed by cTnI. PMID 33327246 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Propofol Small molecule — Intravenous
Subject Sevoflurane Other / unclassified — Inhaled