Myocardial Ischemia Clinical Trial
Official title:
A Comparison of the Effect of Intraoperative Administration of Metoprolol or Esmolol on General Anesthetic Requirement
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
United States | Univeristy of Oklahoma Health Sciences Center Dept. Anesthesiology | Oklahoma | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma |
United States,
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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