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Sevoflurane and Percutaneous Coronary Intervention by Stent

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02671084
Enrollment
701
Registered
2016-02-02
Start date
2016-02-29
Completion date
2020-04-30
Last updated
2020-04-28

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

Conditions

Myocardial Infarction

Keywords

Sevoflurane, Ck-MB

Brief 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.

Interventions

DRUGsevoflurane

compare effect of sevoflurane when administered before PCI

Sponsors

Instituto Dante Pazzanese de Cardiologia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Both gender. 2. Patients with coronary artery disease candidates for coronary angioplasty stent. 3. Cardiac catheterization on an urgent basis. 4. Coronary angioplasty in elective and urgency. 5. Age less than 80 years.

Exclusion criteria

1. Patients aged greater than or equal of 80 years. 2. Angioplasty balloon catheter statement. 3. Myocardial infarction with ST-segment elevation. 4. Angioplasty in saphenous vein grafts in patients after surgical revascularization. 5. Patient pregnant. 6. Dialytic insufficiency renal. 7. Patients submited a urgent cardiac catheterization but not progress with coronary angioplasty stent.

Design outcomes

Primary

MeasureTime frame
Measure level of Ck-MB in all patients24 hours after coronary intervention

Secondary

MeasureTime frameDescription
Length of stay in hospital30 days after coronary interventionIt will be quantified the length of hospital stay of patients who underwent coronary intervention checking if there is difference between groups
Length of stay in Intensive Care Unit (UCI)30 days after coronary interventionThe length of stay in UCI will be quantified if patients who underwent coronary intervention are referred to this sector
mortality rate1 year after coronary intervention

Countries

Brazil

Outcome results

None listed

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