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Tight Hemodynamic Control in Patients Who Are Chronically on Metoprolol

Information source: University Health Network, Toronto
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vascular Disease; Hypertension; Angina; Cardiac Disease

Intervention: Esmolol (Drug); Metoprolol (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: University Health Network, Toronto

Official(s) and/or principal investigator(s):
Scott Beattie, MD, FRCP, Principal Investigator, Affiliation: University Health Network, Toronto General Hospital

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who has been continued on metoprolol (administrated via a nasogastric tube in NPO patients) to a group who has been withdrawn from metoprolol but given an esmolol infusion titrated to HR.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.

Clinical Details

Official title: Tight Hemodynamic Control in Patients Who Are Chronically on Metoprolol: A Study Comparing the Post Op Continuation of the Preoperative Oral Dose Beta Blockers to Intravenous Esmolol Titrated to a Target Heart Rate (HR)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The difference between plasma levels of metoprolol within two groups

Secondary outcome: The amount of time the target heart rate is maintained and the incidence of perioperative hypotension and bradycardia.

Detailed description: The number of high-risk patients undergoing non-cardiac surgery has increased continuously over the last two decades. There is a paucity of data exist about the bioavailability of postoperative administrated beta-blockers. One study reported adequate plasma levels of Propanolol after administration via nasogastric tube but not after oral administration in patient undergoing thyroid surgery. Thus it is possible that patients maintained on oral beta blockers may in fact be experiencing a withdrawal syndrome. Because of the importance of avoiding withdrawal of beta blockers, intravenous administration may be the only alternative in cases where oral administration fails to achieve adequate plasma levels perioperatively. Furthermore, due to changes in pharmacodynamics, intravenous dosage may be the optimal way to achieve tight hemodynamic control. There is, however, no data on the post-operative hemodynamic effects of orally administered beta blockers in patients on chronic beta blockers.

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

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.)

Locations and Contacts

University Heatlh Network, Toronto General Hopsital, Toronto, Ontario M5G 2C4, Canada
Additional Information

Starting date: April 2011
Last updated: April 17, 2015

Page last updated: August 23, 2015

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