Tight Hemodynamic Control in Patients Who Are Chronically on Metoprolol

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study proposes to assess the effect of the standard of care, which is continuation of the pre op beta blocker dose into the post operative period compared to the administration of esmolol titrated to a pre determined target HR. The primary outcome will compare postoperative plasma levels of metoprolol in 2 cohorts in a group who has been continued on metoprolol (administrated via a nasogastric tube in NPO patients) to a group who has been withdrawn from metoprolol but given an esmolol infusion titrated to HR. Secondary outcomes will compare a) the hemodynamic responses, documenting the incidence of unplanned hypotension and bradycardia and b) to compare the effects of Heart rate to the incidence of myocardial ischemia, arrhythmias, delirium and infarction.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Baxter Healthcare Corporation
• Treatments: Esmolol; Metoprolol

Criteria

Patient inclusion criteria:

• Elective vascular surgery

• Any of the following co morbidities

• Diabetes

• Angina

• Congestive heart failure

• A serum creatinine above 176 mmol/l

• All patients must be on stable dose of oral metoprolol (≥ 30 days)

• Age ≥ 20 years and ≤ 80 years

• Written informed consent to participate to the study

Patient exclusion criteria:

• Inability to understand the study protocol

• Prior gastric surgery or small bowel resection

• Pacemaker ( since it precludes the measurement of ST changes)

• Malabsorption syndromes

• Body Mass Index < 18 and > 35

• Any patient with suspected of diagnosed Cerebral vascular disease. (We chose to exclude CVA patients due to the ongoing controversy about the increased incidence of stroke in patients have surgery and who are taking beta-blockers.)