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: 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
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.
- 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
- Placebo Comparator: 2
Clinical Trial Outcome Measures
- Infarct size by area under the curve of cardiac markers.
- Time Frame: 3 days
- 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
- Time Frame: 24 hours
- Patient satisfaction
- Time Frame: 1 hour
Participating in This Clinical Trial
- 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
- 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
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