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A Comparison of the Effects of Intraoperative Adminstration of Metoprolol or Esmolol on General Anesthetic Requirement
This study is not yet open for participant recruitment.
Verified by University of Oklahoma, September 2008
Sponsored by: University of Oklahoma
Information provided by: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00756236
  Purpose

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
Myocardial Ischemia
Drug: Metoprolol
Drug: Esmolol
Drug: Placebo

MedlinePlus related topics: Anesthesia
Drug Information available for: Metoprolol Metoprolol fumarate Metoprolol succinate Metoprolol Tartrate Esmolol Asl 8052
U.S. FDA Resources
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

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Our objective is to clarify if metoprolol, in a dose range used for perioperative cardiac protection, decreases anesthetic requirement. [ Time Frame: During the procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Administration of esmolol, a short-acting beta-receptor antagonist, might reduce the actual anesthetic requirement. [ Time Frame: During the procedure ] [ Designated as safety issue: Yes ]

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
1: Experimental Drug: Metoprolol
60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration
2: Experimental Drug: Esmolol
60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl
3: Placebo Comparator Drug: Placebo

Placebo group:

60 ml syringes of 0.9% NaCl, 5 ml syringes of 0.9% NaCl


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Being older than 18 but, not older than 75
  • Scheduled for surgery under general anesthesia
  • Duration of surgery scheduled as 2 hours or longer

Exclusion Criteria:

  • Intracranial or intrathoracic surgery (due to difficulty using a BIS monitor or frequent need for beta-receptor antagonism)
  • Indication for perioperative beta-receptor antagonism
  • Current use of calcium-channel antagonists
  • History of coronary artery disease
  • History of reactive airway disease
  • History of diabetes or other disorders of glucose metabolism
  • Reported allergy to any of the study drugs
  • Reported substance abuse (except nicotine and caffeine)
  • Use of monoamine oxidase (MAO) inhibitor drugs
  • Hypersensitivity to metoprolol, esmolol and related derivatives, or to any of the excipients of either.
  • Hypersensitivity to other beta-blockers (cross-sensitivity between beta-blockers can occur).
  • Sick-sinus Syndrome.
  • Heart block greater than first degree, cardiogenic shock, and overt cardiac failure.
  • Significant first-degree heart block (P-R interval greater than or equal to 0.24 sec; systolic pressure < 100mmHg; or moderate- to-severe cardiac failure).
  • Severe peripheral arterial circulatory disorders.
  • Pheochromocytoma.
  • Baseline heart rate of < 60
  • Systolic pressure less than 100 mm Hg
  • Pregnant women
  • Prisoners
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756236

Contacts
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

Sponsors and Collaborators
University of Oklahoma
  More Information

Univeristy of Oklahoma Health Sciences Center  This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:
Heart Diseases
Esmolol
Metoprolol succinate
Myocardial Ischemia
Vascular Diseases
Ischemia
Metoprolol

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009