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

Myocardial Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00756236
• Other study ID #: 1638
• Status: Active, not recruiting
• Phase: N/A
• First received: September 19, 2008
• Last updated: December 2, 2014
• Start date: October 2008
• Est. completion date: October 2015

Study information

• Verified date: December 2014
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Drug:
• Metoprolol
60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration
• Esmolol
60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl
• Placebo
Placebo group: 60 ml syringes of 0.9% NaCl, 5 ml syringes of 0.9% NaCl

Locations

Country	Name	City	State
United States	Univeristy of Oklahoma Health Sciences Center Dept. Anesthesiology	Oklahoma	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Our objective is to clarify if metoprolol, in a dose range used for perioperative cardiac protection, decreases anesthetic requirement.		During the procedure	Yes
Secondary	Administration of esmolol, a short-acting beta-receptor antagonist, might reduce the actual anesthetic requirement.		During the procedure	Yes

External Links

•   University of Oklahoma Health Sciences Center