An interventional study of Metoprolol and Esmolol in Myocardial Ischemia, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-07-31.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Other
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.
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.
3,233 studies on the registry are indexed under Myocardial Ischemia; 396 are open to participants now.
This study's enrollment of 60 is below the median of 120 across 1,895 interventional studies indexed under Myocardial Ischemia.
Browse Myocardial Ischemia studies →University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml \& 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment.
Drug: Metoprolol
Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml \& 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment.
Drug: Esmolol
Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml \& 5ml syringes.
Drug: P-Group
60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration
Also known as: M-Group
60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl
Also known as: E-Group
0.9%NaCl dispensed in 60ml \& 5ml syringes
Also known as: Placebo Comparator
Area Under the Curve of etSEV Over the First Hour
We will measure the amount of Sevoflurane used to achieve the same level Bispectral Index. Each patient will have their percentage of sevoflurane in expired breath measured every 5 minutes for 2 hours, resulting in 24 data points per person. The primary endpoint will be area under the curve (AUC) for each subject for the first hour.
Time frame: Every 5 minutes for 2 hours
Subjects were consented at the pre-surgical clinical visit if they were outpatients. Inpatients were consented while they were in the hospital. Each patient were provided with a copy of the informed consent and be given at least 12 hours to make a decision.
| Milestone | M-Group | E-Group | P-Group |
|---|---|---|---|
| Started | 20 | 20 | 20 |
| Completed | 20 | 20 | 20 |
| Not completed | 0 | 0 | 0 |
We will measure the amount of Sevoflurane used to achieve the same level Bispectral Index. Each patient will have their percentage of sevoflurane in expired breath measured every 5 minutes for 2 hours, resulting in 24 data points per person. The primary endpoint will be area under the curve (AUC) for each subject for the first hour.
| percent*hour | M-Group | E-Group | P-Group |
|---|---|---|---|
| Area Under the Curve of etSEV Over the First Hour | 1.77 ± 0.38 | 1.46 ± 0.29 | 1.73 ± 0.47 |
Collected over From start of the surgical procedure to one day after the surgery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| M-Group | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| E-Group | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| P-Group | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | M-Group | E-Group | P-Group | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 18 | 17 | 55 |
| >=65 years | 0 | 2 | 3 | 5 |
| Age, Continuous(YEARS) | M-Group | E-Group | P-Group | Total |
|---|---|---|---|---|
| Mean | 44 ± 13.3 | 49 ± 11.8 | 48 ± 15.2 | 46.8 ± 13.2 |
| Sex: Female, Male(Participants) | M-Group | E-Group | P-Group | Total |
|---|---|---|---|---|
| Female | 12 | 17 | 14 | 43 |
| Male | 8 | 3 | 6 | 17 |
| Region of Enrollment(participants) | M-Group | E-Group | P-Group | Total |
|---|---|---|---|---|
| United States | 20 | 20 | 20 | 60 |
Plan to share: No
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Oklahoma