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A Comparison of the Effects of Intraoperative Administration of Metoprolol or Esmolol on General Anesthetic Requirement

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University of Oklahoma.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
University of Oklahoma Identifier:
First received: September 19, 2008
Last updated: December 2, 2014
Last verified: December 2014

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Comparison of the Effect of Intraoperative Administration of Metoprolol or Esmolol on General Anesthetic Requirement

Resource links provided by NLM:

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 ]

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

Estimated Enrollment: 60
Study Start Date: October 2008
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
metoprolol at 1mg/ml concentration
Drug: Metoprolol
60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration
Experimental: 2
esmolol at 10 mg/ml concentration
Drug: Esmolol
60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl
Placebo Comparator: 3 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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00756236

United States, Oklahoma
Univeristy of Oklahoma Health Sciences Center Dept. Anesthesiology
Oklahoma, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Principal Investigator: Pramod Chetty, MD Faculty, Anesthesiology
  More Information

Additional Information:
Responsible Party: University of Oklahoma Identifier: NCT00756236     History of Changes
Other Study ID Numbers: 1638
Study First Received: September 19, 2008
Last Updated: December 2, 2014

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017