Esmolol for Treatment of Perioperative Tachycardia

• Status: Terminated
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Baxter Healthcare Corporation
• Treatments: Esmolol

Criteria

Inclusion Criteria:

1. Males or Females

2. Age > 40y/o

3. Scheduled high risk (ASA II-IV) non-cardiac surgery with anticipated 12 hour post-operative ICU care

4. Written informed consent

5. Patients on a stable chronic oral beta-blocker therapy

6. 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

Exclusion Criteria:

1. Active bleeding

2. Untreated left main disease

3. Active cardiac condition (eg unstable angina pectoris, acute exacerbation of CHF, serious arrhythmias, symptomatic valve disease)

4. Preoperative positive troponin T

5. Contraindication for esmolol use

6. Previous allergy or intolerance to esmolol

7. Cancer with an expected life expectancy < 6 months

8. Pregnancy or lactating or planning to become pregnant

9. Failure to provide informed consent, unable to understand or follow instructions.

10. History of drug allergy or idiosyncrasy to beta-adrenergic drugs

11. Recent history (within 1 year) of drug or alcohol abuse

12. Patients with a Pacemaker

13. Abnormal liver function Child-Pugh - B

14. Body Mass Index > 45

15. Reactive airway disease (defined as a history of hospitalization with status asthmaticus within the past one year)

16. Surgery scheduled to begin after 2pm