Tight Hemodynamic Control in Patients Who Are Chronically on Metoprolol
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01404767 |
Recruitment Status
:
Terminated
(Enrollment slow over 2 years a change in the population less on metoprolol than initially anticipated)
First Posted
: July 28, 2011
Last Update Posted
: April 21, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vascular Disease Hypertension Angina Cardiac Disease | Drug: Esmolol Drug: Metoprolol | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | April 2011 |
Actual Primary Completion Date : | April 2011 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Metoprolol oral dose or Placebo infusion |
Drug: Metoprolol
The night and morning before surgery, the patients in the metoprolol arm will receive their standard dose of beta blocker metoprolol.These patients will receive their daily beta blockers orally or via nasogastric tube postoperatively if they are NPO (Group A).
|
Experimental: Esmolol infusion or Placebo oral dose |
Drug: Esmolol
Baseline treatment consists of a bolus of 500ug/kg/min followed by an infusion of 50ug/kg/min for 4 minutes and titrating in increment of 50ug/kg/min up to a maximum of 300ug/kg/min to maintain a HR within 10% of the target HR (≤ 70 bpm), which is 70± 7 bpm.
|
- The difference between plasma levels of metoprolol within two groups [ Time Frame: 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.
- The amount of time the target heart rate is maintained and the incidence of perioperative hypotension and bradycardia. [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404767
Canada, Ontario | |
University Heatlh Network, Toronto General Hopsital | |
Toronto, Ontario, Canada, M5G 2C4 |
Principal Investigator: | Scott Beattie, MD, FRCP | University Health Network, Toronto General Hospital |
Responsible Party: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT01404767 History of Changes |
Other Study ID Numbers: |
10-0713-A |
First Posted: | July 28, 2011 Key Record Dates |
Last Update Posted: | April 21, 2015 |
Last Verified: | April 2015 |
Keywords provided by University Health Network, Toronto:
Vascular surgery esmolol hemodynamic control |
Additional relevant MeSH terms:
Vascular Diseases Heart Diseases Cardiovascular Diseases Metoprolol Esmolol Anti-Arrhythmia Agents Antihypertensive Agents Sympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |