Sevoflurane In Acute Myocardial Infarction

Overview

Ischemic postconditioning can reduce myocardial injury following myocardial infarction. A potential pharmacological agent is the anesthetic Sevoflurane. The investigators' hypothesis is that sevoflurane during primary percutaneous coronary intervention (PCI) will reduce infarct size.

Full Title of Study: “Sevoflurane Sedation During Primary Percutaneous Coronary Intervention.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2013

Detailed Description

Patients with first STEMI that will be treated by primary PCI, will be randomized to sedation with Sevoflurane during the procedure or to usual care.

Interventions

  • Drug: Oxygen + Sevoflurane
    • Oxygen with end-tidal MAC of Sevoflurane 0.5 during PCI.
  • Drug: Oxygen (placebo)
    • Control will receive oxygen only.

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Sevoflurane
  • Placebo Comparator: 2
    • Oxygen

Clinical Trial Outcome Measures

Primary Measures

  • Infarct size by area under the curve of cardiac markers.
    • Time Frame: 3 days

Secondary Measures

  • Left ventricular function.
    • Time Frame: Six month
  • ST segment elevation resolution
    • Time Frame: 90 minutes
  • TIMI flow
    • Time Frame: 60 minutes
  • Renal function
    • Time Frame: 48 hours
  • CRP
    • Time Frame: 24 hours
  • Patient satisfaction
    • Time Frame: 1 hour

Participating in This Clinical Trial

Inclusion Criteria

  • First STEMI, presenting within 6 hours after the onset of chest pain – Symptoms lasting > 30 minutes – Persistent ST-segment elevation > 0.1 mV in 2 or more contiguous leads Exclusion Criteria:

  • Hypersensitivity to sevoflurane or other halogenated agents – Malignant hyperthermia – Cardiac arrest – Cardiogenic shock – Previous myocardial infarction or coronary bypass surgery – Pre-infarction angina – Heart failure (NYHA III/IV) – Chronic inflammatory disease – Severe renal impairment – Hepatic dysfunction – Use of Glyburide

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lawson Health Research Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shahar Lavi, Principal Investigator – Lawson Health Research Institute
  • Overall Official(s)
    • Shahar Lavi, MD, Principal Investigator, Lawson Health Research Institute

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.