A Comparison of the Effects of Intraoperative Administration of Metoprolol or Esmolol on General Anesthetic Requirement
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|Official Title:||A Comparison of the Effect of Intraoperative Administration of Metoprolol or Esmolol on General Anesthetic Requirement|
- Our objective is to clarify if metoprolol, in a dose range used for perioperative cardiac protection, decreases anesthetic requirement. [ Time Frame: During the procedure ] [ Designated as safety issue: Yes ]
- Administration of esmolol, a short-acting beta-receptor antagonist, might reduce the actual anesthetic requirement. [ Time Frame: During the procedure ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
metoprolol at 1mg/ml concentration
60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration
esmolol at 10 mg/ml concentration
60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl
|Placebo Comparator: 3||
60 ml syringes of 0.9% NaCl, 5 ml syringes of 0.9% NaCl
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756236
|Contact: Pramod Chetty, MD||405-271-4351||Pramod-Chetty@ouhsc.edu|
|Contact: Qaiser S Khan, MD,MPH||405-271-8001 ext firstname.lastname@example.org|
|United States, Oklahoma|
|Univeristy of Oklahoma Health Sciences Center Dept. Anesthesiology||Recruiting|
|Oklahoma, Oklahoma, United States, 73104|
|Contact: Pramod Chetty, M.D 405-271-4351 Pramod-Chetty@ouhsc.edu|
|Contact: Qaiser Khan, MD,MPH 405-271-8001 ext 36016 email@example.com|
|Principal Investigator: Pramod Chetty, MD|