Tight Hemodynamic Control in Patients Who Are Chronically on Metoprolol

Phase 4

Terminated

• Conditions: Hypertension; Vascular Disease; Angina; Cardiac Disease
• Interventions: Drug: Metoprolol; Drug: Esmolol

• Registration Number: NCT01404767
• Lead Sponsor: University Health Network, Toronto

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who has been continued on metoprolol (administrated via a nasogastric tube in NPO patients) to a group who has been withdrawn from metoprolol but given an esmolol infusion titrated to HR.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

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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-04
• Study First Submitted: 2011-06-21
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-28
• Study Completion: 2013-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-17
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metoprolol oral dose or Placebo infusion	Metoprolol	-
Esmolol infusion or Placebo oral dose	Esmolol	-

Primary Outcome Measures

Name	Time	Method
The difference between plasma levels of metoprolol within two groups	0,1, 2, 4, 8, 12, 24 hours post intervention	Comparisons measured in the pre-operative to intra-operative and post operative periods within metoprolol arm as well as between esmolol arm and metoprolol arm. Plasma levels will be correlated with both the hemodynamic response (HR) and the incidence of postoperative ischemia. The covariates (HR, BP, HR variability, etc) on PK/PD correlation will be examined.

Secondary Outcome Measures

Name	Time	Method
The amount of time the target heart rate is maintained and the incidence of perioperative hypotension and bradycardia.	Data will be recorded for 48 hours from arrive to the recovery area	Additional assessments include cardiovascular morbidity and mortality including 30-day mortality, myocardial infarction, new cardiac arrhythmia, congestive heart failure, and renal failure, the incidence of post operative delirium, transient ischemic attack, stroke, and length of hospital stay.

Trial Locations

Locations (1)

University Heatlh Network, Toronto General Hopsital; 🇨🇦 Toronto, Ontario, Canada