A Comparison of the Effects of Intraoperative Adminstration of Metoprolol or Esmolol on General Anesthetic Requirement
Information source: University of Oklahoma
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myocardial Ischemia
Intervention: Metoprolol (Drug); Esmolol (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Oklahoma Overall contact:
Mehmet Ozcan, MD, Phone: 405-271-4351, Email: mehmet-ozcan@ouhsc.edu
Summary
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.
Clinical Details
Official title: A Comparison of the Effect of Intraoperative Admistration of Metoprolol or Esmolol on General Anesthetic Requirement
Study design: Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Our objective is to clarify if metoprolol, in a dose range used for perioperative cardiac protection, decreases anesthetic requirement.
Secondary outcome: Administration of esmolol, a short-acting beta-receptor antagonist, might reduce the actual anesthetic requirement.
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Mehmet Ozcan, MD, Phone: 405-271-4351, Email: mehmet-ozcan@ouhsc.edu
Univeristy of Oklahoma Health Sciences Center Dept. Anesthesiology, Oklahoma, Oklahoma 73104, United States; Recruiting
Mehmet Ozcan, MD, Phone: 405-271-4351, Email: Mehmet-ozcan@ouhsc.edu
Qaiser Khan, MD,MPH, Phone: 405-271-8001, Ext: 36016, Email: qaiser-khan@ouhsc.edu
Mehmet Ozcan, MD, Principal Investigator
Additional Information
Univeristy of Oklahoma Health Sciences Center
Starting date: November 2008
Ending date: December 2009
Last updated: May 28, 2009
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