NCT02671084

Sevoflurane and Percutaneous Coronary Intervention by Stent

Effect of Sevoflurane on CKMB Release After PCI With Drug-eluting Stents: a Randomised Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 701 (actual)
• Sponsor: Instituto Dante Pazzanese de Cardiologia · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Several published clinical studies have shown the benefit of using inhaled anesthetic agents in patients undergoing coronary artery bypass graft(CABG). These benefits involve functional state of the heart and reduction damage to the organ. These events are related to intracellular phenomena that result in intracellular calcium homeostasis giving physical and functional benefits to the heart. Also disclosed is a modulation of the inflammatory response to endothelial level with resulting protective character to the coronary bed. 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. Even in smaller increases than 3 times baseline, a criterion that defines myocardial infarction, clinical impact can already be found. Increase in CK-MB more than 100% of baseline can represents a problem to the patients. This elevation of CK - MB is associated with various factors such as age, characteristic of the lesion, clinical status of the patient, inferring that endovascular procedures of coronary, simple or complex, have associated myocardial damage, which depending on the intensity of the damage, results in increased morbidity and mortality. BACKGROUND AND OBJECTIVES: Check for reduction in the percentage of patients that release CK -MB at levels above the 100% baseline in patients anesthetized with sevoflurane compared to the control group. 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.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	sevoflurane	compare effect of sevoflurane when administered before PCI

Timeline

• Start date: 2016-02-01
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2016-02-02
• Last updated: 2020-04-28

Locations

1 site across 1 country: Brazil