Sevoflurane and Percutaneous Coronary Intervention by Stent

April 24, 2020 updated by: RONALDO ROSSI JUNIOR, Instituto Dante Pazzanese de Cardiologia

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

701

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04012-909
        • Institute Dante Pazzanese of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sevoflurane Group
Sevoflurane Group called group A patients will receive sevoflurane. The patients of group A will receive facial mask properly attached to your face, inspiratory fraction of sevoflurane 3%, with therapeutic target of 1.2% expired fraction into spontaneously breathing.This exposure will during 30 min. Than, the mask will remove of the face and the patient will spontaneously breathing in ambient air during 10 min. This procedure is sufficient to induce the pre anesthetic conditioning in the group exposed to sevoflurane. After the end of this exhibition, patients will be allowed to enter the catheterization laboratory for angioplasty, no more any anesthetic agent will be administer until the end of his procedure.
Drug: sevoflurane
compare effect of sevoflurane when administered before PCI
PLACEBO_COMPARATOR: Control Group
Control Group called group B patients who will not receive sevoflurane. The patient of group B will receive facial mask properly attached to your face into spontaneously breathing.This exposure will during 30 min. Than, the mask will remove of the face and the patient will spontaneously breathing in ambient air during 10 min. After the end of this exhibition, patients will be allowed to enter the catheterization laboratory for angioplasty, no more any anesthetic agent will be administer until the end of his procedure.
Drug: sevoflurane
compare effect of sevoflurane when administered before PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure level of Ck-MB in all patients
Time Frame: 24 hours after coronary intervention
24 hours after coronary intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay in hospital
Time Frame: 30 days after coronary intervention
It will be quantified the length of hospital stay of patients who underwent coronary intervention checking if there is difference between groups
30 days after coronary intervention
Length of stay in Intensive Care Unit (UCI)
Time Frame: 30 days after coronary intervention
The length of stay in UCI will be quantified if patients who underwent coronary intervention are referred to this sector
30 days after coronary intervention
mortality rate
Time Frame: 1 year after coronary intervention
1 year after coronary intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Dante Pazzanese de Cardiologia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2016

Primary Completion (ACTUAL)

April 1, 2020

Study Completion (ACTUAL)

April 1, 2020

Study Registration Dates

First Submitted

January 20, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (ESTIMATE)

February 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 090106/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be published in journals

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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