Esmolol for Treatment of Perioperative Tachycardia

Stopped early · Phase 3

Conditions studied: High-risk, Non-cardiovascular Surgeries

In brief

The purpose of this study is to find out if Esmolol is a safe and effective alternative treatment compared to standard treatment using a long acting beta blocker drug, in controlling abnormal heart rate before, during and immediately after surgery.

Key facts

Study ID

NCT01208402

Run by

Duke University

People needed

76

Starts

2010-09-01

Expected to finish

2013-07-01

Last updated by the study team

2014-12-12

Who can join

Age: 41 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or Females
• Age > 40y/o
• Scheduled high risk (ASA II-IV) non-cardiac surgery with anticipated 12 hour post-operative ICU care
• Written informed consent
• Patients on a stable chronic oral beta-blocker therapy
• Revised Cardiac Risk Index 1(below) Cardiac Risk Index 1 or greater (below)
• a history of coronary disease
• a history of congestive heart failure
• a history of treated diabetes
• a history of cerebrovascular disease
• a history of chronic renal failure

You may not qualify if…

• Active bleeding
• Untreated left main disease
• Active cardiac condition (eg unstable angina pectoris, acute exacerbation of CHF, serious arrhythmias, symptomatic valve disease)
• Preoperative positive troponin T
• Contraindication for esmolol use
• Previous allergy or intolerance to esmolol
• Cancer with an expected life expectancy < 6 months
• Pregnancy or lactating or planning to become pregnant
• Failure to provide informed consent, unable to understand or follow instructions.
• History of drug allergy or idiosyncrasy to beta-adrenergic drugs
• Recent history (within 1 year) of drug or alcohol abuse
• Patients with a Pacemaker
• Abnormal liver function Child-Pugh - B
• Body Mass Index > 45
• Reactive airway disease (defined as a history of hospitalization with status asthmaticus within the past one year)
• Surgery scheduled to begin after 2pm

Where it is running

• Durham VA Medical Center — Durham, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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