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Sponsored by: |
University of Oklahoma |
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Information provided by: | University of Oklahoma |
ClinicalTrials.gov Identifier: | NCT00756236 |
We will compare three study groups receiving metoprolol, esmolol, or placebo. Level of anesthesia will be titrated to achieve the same range of BIS value in all groups. Our hypothesis is that the metoprolol and esmolol groups will require a lower level of anesthetic agent to achieve the targeted BIS range, compared to the placebo group.
Our objective is to clarify if metoprolol, in a dose range used for perioperative cardiac protection, decreases anesthetic requirement.
Condition | Intervention |
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Myocardial Ischemia |
Drug: Metoprolol Drug: Esmolol Drug: Placebo |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Comparison of the Effect of Intraoperative Admistration of Metoprolol or Esmolol on General Anesthetic Requirement |
Estimated Enrollment: | 60 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Metoprolol
60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration
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2: Experimental |
Drug: Esmolol
60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl
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3: Placebo Comparator |
Drug: Placebo
Placebo group: 60 ml syringes of 0.9% NaCl, 5 ml syringes of 0.9% NaCl |
Beta-receptor antagonists are commonly used in the perioperative setting. These agents have been shown to decrease the incidence of perioperative myocardial ischemia and are recommended by a recent practice guideline in certain patient groups.1 Besides protection from ischemia, there are other situations where beta-receptor antagonists are used intraoperatively such as control of the sympathetic response to tracheal intubation and certain types of surgical stimuli.
There is new evidence suggesting that administration of esmolol, a short-acting beta-receptor antagonist, might reduce the actual anesthetic requirement. This was initially shown by studies in which esmolol decreased the amount of anesthetic required to prevent movement after skin incision.2;3 Subsequent studies used bispectral index (BIS) as an endpoint and demonstrated decreased BIS values in subjects receiving esmolol during general anesthesia. 4;5
This anesthetic-sparing effect observed with esmolol has not been prospectively studied with other beta-receptor antagonists. Since perioperative beta-blockade is commonly achieved using longer acting agents such as metoprolol or atenolol, it is clinically relevant to understand the effects of these medications on anesthetic requirement. We aim to conduct a prospective, randomized, controlled, double-blind study to compare the anesthetic-sparing effect of metoprolol and esmolol administered intraoperatively.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mehmet Ozcan, MD | 405-271-4351 | mehmet-ozcan@ouhsc.edu |
Contact: QAISER S KHAN, MD,MPH | 405-271-8001 ext 36016 | qaiser-khan@ouhsc.edu |
Responsible Party: | OUHSC ( Dr. Mehmet Ozcan ) |
Study ID Numbers: | 13382 |
Study First Received: | September 19, 2008 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00756236 |
Health Authority: | United States: Food and Drug Administration |
Heart Diseases Esmolol Metoprolol succinate Myocardial Ischemia |
Vascular Diseases Ischemia Metoprolol |
Sympatholytics Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Pathologic Processes Autonomic Agents Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Peripheral Nervous System Agents Anti-Arrhythmia Agents |