Expired Study
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Oklahoma, Oklahoma 73104


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.


Study summary:

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.


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


Study is Available At:


Original ID:

1638


NCT ID:

NCT00756236


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Oklahoma


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Pramod Chetty, MD
Principal Investigator
Faculty, Anesthesiology

Study Dates

Start Date:October 2008
Completion Date:October 2015
Completion Type:Anticipated
Primary Completion Date:October 2015
Primary Completion Type:Anticipated
Verification Date:December 2014
Last Changed Date:December 2, 2014
First Received Date:September 19, 2008

Study Outcomes

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

Study Interventions

Intervention Type:Drug
Name:Metoprolol
Description:60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration
Arm Name:1
Intervention Type:Drug
Name:Esmolol
Description:60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl
Arm Name:2
Intervention Type:Drug
Name:Placebo
Description:Placebo group: 60 ml syringes of 0.9% NaCl, 5 ml syringes of 0.9% NaCl
Arm Name:3

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:3
Study Arm Type:Experimental
Arm Name:2
Description:esmolol at 10 mg/ml concentration
Study Arm Type:Experimental
Arm Name:1
Description:metoprolol at 1mg/ml concentration

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Oklahoma

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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