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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Oklahoma
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00756236
First received: September 19, 2008
Last updated: January 15, 2013
Last verified: January 2013
  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.


Condition Intervention
Myocardial Ischemia
Drug: Metoprolol
Drug: Esmolol
Drug: Placebo

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
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)
Arms Assigned Interventions
Experimental: 1
metoprolol at 1mg/ml concentration
Drug: Metoprolol
60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration
Experimental: 2
esmolol at 10 mg/ml concentration
Drug: Esmolol
60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl
Placebo Comparator: 3 Drug: Placebo

Placebo group:

60 ml syringes of 0.9% NaCl, 5 ml syringes of 0.9% NaCl


Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756236

Contacts
Contact: Pramod Chetty, MD 405-271-4351 Pramod-Chetty@ouhsc.edu
Contact: Qaiser S Khan, MD,MPH 405-271-8001 ext 36016 qaiser-khan@ouhsc.edu

Locations
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    qaiser-khan@ouhsc.edu   
Principal Investigator: Pramod Chetty, MD         
Sponsors and Collaborators
University of Oklahoma
  More Information

Additional Information:
No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00756236     History of Changes
Other Study ID Numbers: 14301
Study First Received: September 19, 2008
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Vascular Diseases
Anesthetics
Anesthetics, General
Esmolol
Metoprolol
Metoprolol succinate
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympatholytics
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014