drugset / Trial / NCT02671084

Sevoflurane and Percutaneous Coronary Intervention by Stent

NCT02671084 ↗

Phase 4 Terminated 701 enrolled Instituto Dante Pazzanese de Cardiologia
RandomizedParallel-groupDouble-blindTreatment

Summary

Increase in CK-MB after percutaneous coronary angioplasty more than 100% of baseline can represents a problem to the patients resulting in increase of morbidity and mortality. Patients submitted of coronary angioplasty procedures can release in varying degrees of creatine kinase, MB isoform (CK - MB), on the order of 30% of all angioplasty. Possibly patients who will receive sevoflurane experience a higher level of cardiac cell protection with lower incidence in the release of CK - MB values in excess of 100% baseline.

Timeline

Start
2016-02
Primary completion
2020-04
Completion
2020-04

Outcome

Missed primary endpoint

Stopped: “interim analysis suggests futility”

paper Sixteen patients had detectable cardiac troponin I levels after stenting procedures, with no difference between groups: 10 in the sevoflurane group (16 patients) versus 6 in the placebo group (14 patients) (p = 0.3). PMID 18662628 ↗

paper Myocardial damage measured by cardiac troponin release was not reduced by the volatile anesthetic sevoflurane during interventional cardiology procedures in this study. PMID 18662628 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sevoflurane Other / unclassified 3 % Inhaled

Indications