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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00756236
Other study ID # 1638
Secondary ID
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


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
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