Perioperative esmolol infusion for haemodynamic stability during major vascular surgery.
- Conditions
- 100110821000318410003216coronary artery diseasesclerosis of the bloodvessels of the heart
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 260
Patients are eligible for inclusion for the study at the Erasmus Medical Centre if they are:
1. Scheduled for arterial vascular surgery, including abdominal aortic aneurysm repair, abdominal aortic stenosis surgery, lower limb arterial reconstruction or carotid artery stenosis repair
2. Provide informed consent
Potential subjects will be excluded with any of the following:
1. Active bleeding
2. Untreated left main disease
3. Active cardiac condition such as unstable angina pectoris, active congestive heart failure, serious cardiac arrhythmias, symptomatic valvular disease, recent MI< 6 months.
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. Excessive alcohol use
9. Pregnancy or planning to become pregnant
10. Failure to provide informed consent
11.Failure to monitor heart rate with the continuous 12-lead electrocardiography because of surgery or baseline electrocardiographic abnormalities.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is hemodynamic stability during the first 24 hours after<br /><br>the start of surgery, where hemodynamic stability is defined as total length of<br /><br>heart rate outside the target window presented in minutes. the target window is<br /><br>defined as a heart rate between 60 and 80 beats per minute. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The key secondary study outcome is the occurrence of myocardial ischemia,<br /><br>defined as either transient electrocardiographic signs of ischemia or Troponin<br /><br>T release or both. In patients with tachycardia and ischemia, the use of rescue<br /><br>medication is considered to be a secondary study endpoint as well, where the<br /><br>dose is noted for every patient. Secondary outcomes also include other safety<br /><br>parameters such as the occurrence of bradycardia (i.e. HR 50 BPM or less) and<br /><br>the occurrence of stroke and transient ischemic attacks (TIA). another<br /><br>secondary outcome measure is 'area under the curve' of episodes of tachycardia. </p><br>